RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Priority Review (China), Conditional marketing approval (European Union), Fast Track (European Union), Conditional marketing approval (China), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 10256963L

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Sequence Code 315617079L

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Sequence Code 432311657H

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Sequence Code 432311660H

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Clinical Trials associated with Elranatamab

NCT06832865

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma

This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.

Start Date01 Aug 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

NCT06988488

/ RecruitingPhase 1/2

A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).

Start Date07 Oct 2025

Sponsor / Collaborator

Celgene Corp.

NCT07190261

/ Not yet recruitingPhase 2IIT

A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia

Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.

Start Date18 Sep 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Elranatamab

100 Translational Medicine associated with Elranatamab

100 Patents (Medical) associated with Elranatamab

Literatures (Medical) associated with Elranatamab

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States

Article

Author: Garrison, Louis P. ; Fowler, Jessica ; Lin, Dee ; Van Sanden, Suzy ; Marshall, Alex ; Wu, Bingcao ; Le, Hoa H. ; Paner, Agne ; Goble, Joe ; Mu, Fan ; Gordan, Lucio N. ; Bensimon, Arielle G. ; Ammann, Eric ; Zhang, Xinke ; Min, Elissa E. ; Kim, Nina

AIMS:

Teclistamab and elranatamab are bispecific antibodies recently approved for the treatment of triple class-exposed relapsed/refractory multiple myeloma (RRMM). This study assessed the relative efficacy and economic value of teclistamab and elranatamab through a matching-adjusted indirect comparison (MAIC) and cost per responder analysis using data from the MajesTEC-1 (NCT03145181/NCT04557098) and MagnetisMM-3 (NCT04649359) trials.

MATERIALS AND METHODS:

The MAIC compared overall response rate (ORR) between the therapies after weighting individual patient data from MajesTEC-1 to match key baseline characteristics in MagnetisMM-3. Matched covariates included age, refractory status, prior lines of therapy, extramedullary disease, performance status, disease stage, and cytogenetic risk profile. Cost per responder was calculated based on estimated per-patient drug acquisition and administration cost (2024 United States dollars) over 6 months divided by ORR. One-way and probabilistic sensitivity analyses were conducted to characterize uncertainty.

RESULTS:

The ORRs were 63.0% for teclistamab before matching (N = 165), 61.4% for teclistamab after matching (effective sample size = 92), and 61.0% for elranatamab (N = 123) (odds ratio after matching: 1.02; 95% confidence interval [CI]: 0.59, 1.77). Per-patient costs were estimated to be $231,435 for teclistamab and $285,201 for elranatamab (difference: -$53,766; 95% confidence interval [CI]: -$59,094, -$48,311), yielding costs per responder of $376,930 and $467,730, respectively (difference: --$90,800; 95% CI: -$183,680, $8,148).

LIMITATIONS:

Because MajesTEC-1 and MagnetisMM-3 are single-arm trials, the MAIC was unanchored and therefore susceptible to confounding from any unadjusted effect modifiers or prognostic variables.

CONCLUSIONS:

Teclistamab was associated with significantly lower treatment costs and numerically lower cost per responder than elranatamab in triple class-exposed RRMM.

14 Oct 2025·Blood Advances

Tocilizumab prophylaxis for patients with multiple myeloma treated with bispecific antibodies

Article

Author: Kazandjian, Dickran ; Landgren, Ola ; Diamond, Benjamin ; Kowalski, Andrew ; Coffey, David ; Pandey, Abhishek ; Lykon, Jill ; Maura, Francesco ; Kaddoura, Marcella ; Hoffman, James

Abstract:

Bispecific antibodies for treatment for multiple myeloma are highly effective but commonly cause cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Emerging data indicate that prophylactic tocilizumab may reduce CRS, without impacting efficacy. We administered a single dose of tocilizumab before the first dose of bispecific antibodies to 119 patients to determine the impact on CRS in a real-world setting including B-cell maturation antigen × CD3– and G-protein–coupled receptor class C group 5 member D × CD3–targeted antibodies. The best overall response rate was 65.7% (binomial 95% confidence interval [CI], 55.8-74.7). We observed a low overall rate of CRS (10.1%; 95% CI, 5.3-17). For teclistamab, elranatamab, linvoseltamab, and talquetamab individually, the CRS rate was 8.9%, 12.5%, 0%, and 13%, respectively. The overall rate of ICANS (5.9%; 95% CI, 2.4-11.7) was low but similar to rates without prophylactic tocilizumab. CRS was limited to grade 1 for 10 of 12 events. There were no grade 3 CRS events, and no additional doses of tocilizumab or corticosteroids were given for CRS. Our real-world evidence results suggest that tocilizumab may be effective as a preventive, rather than reactive, measure to prevent CRS without compromising efficacy.

23 Sep 2025·Blood Advances

Immunoglobulin prophylaxis should be initiated after bispecific antibody therapy in multiple myeloma, regardless of IgG levels

Review

Author: Bagal, Bhausaheb ; Mehra, Nikita ; Cirstea, Diana D. ; Puliafito, Benjamin R. ; McCaughan, Georgia J. ; Midha, Shonali ; Banerjee, Rahul ; Rejeski, Kai ; Kumar, Nikhil M. ; Kaur, Gurbakhash ; Raje, Noopur S. ; Mohan, Meera

Abstract:

Bispecific antibodies (bsAbs), such as teclistamab, elranatamab, linvoseltamab, and talquetamab, have impressive efficacy in multiple myeloma (MM) but come with substantial infectious risks that do not dissipate over time. Immunoglobulin replacement therapy (IgRT), which includes IV and subcutaneous (SC) immunoglobulins, may lower these risks. In this viewpoint, we contrast primary IgRT prophylaxis (initiation regardless of IgG levels) with preemptive IgRT treatment (initiation only once IgG levels fall below a certain threshold) in this setting. We make evidence-based arguments for primary prophylaxis as a safer and simpler approach than preemptive IgG-guided IgRT. We also discuss strategies to improve the cost-effectiveness of IV and SC immunoglobulins across the world. Given the overwhelmingly favorable benefit-risk profile of IgRT, coupled with the limitations inherent to IgG measurements in MM, withholding IgRT access based on arbitrary IgG thresholds is neither scientifically sound nor clinically appropriate for patients with MM who are receiving bsAb therapy.

News (Medical) associated with Elranatamab

16 Oct 2025

·ir.c4therapeutics.com

C4 Therapeutics Announces Pricing of $125 Million Underwritten Offering

$125 Million in Upfront Proceeds Expected to Fund Next Phase of Cemsidomide Multiple Myeloma Development Including Registrational Phase 2 Trial in Combination with Dexamethasone and Phase 1b Trial in Combination with Elranatamab Potential to Earn up to an Additional $225 Million in Proceeds WATERTOWN, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the pricing of an underwritten offering to a select group of institutional investors consisting of 21,895,000 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase an aggregate of up to 28,713,500 shares of its common stock. Each share of common stock and each pre-funded warrant is accompanied by a Class A Warrant and a Class B Warrant, each to purchase one share of common stock (or pre-funded warrant in lieu thereof) at an exercise price of $2.22 per share. The offering was led by RA Capital Management with participation from existing shareholders including OrbiMed, Soleus Capital, Lynx1 Capital Management, and Bain Capital Life Sciences. The Class A Warrants are exercisable at any time through the earlier of (i) 30 days after the achievement of a trigger tied to the clinical results from the planned Phase 1b trial of cemsidomide with elranatamab, or (ii) five years from the date of issuance. The Class B Warrants are exercisable at any time prior to the fifth anniversary of the date of issuance and, under certain circumstances based on stock appreciation, C4T may require the mandatory exercise of the warrants. The shares of common stock (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.47 per share of common stock and accompanying warrants, and the pre-funded warrants (with accompanying Class A and Class B Warrants) are being sold at a combined price of $2.4699 per pre-funded warrant and accompanying warrants, which represents the per share price of the common stock less the $0.0001 per share exercise price for each pre-funded warrant. All securities in the offering are being sold by C4T. The aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses and excluding any proceeds from potential exercise of the Class A and Class B Warrants and nominal proceeds from potential exercise of the pre-funded warrants, are expected to be $125.0 million. If all Class A and Class B Warrants and pre-funded warrants are exercised, the aggregate gross proceeds to C4T from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $349.7 million. The offering is expected to close on or about October 17, 2025, subject to the satisfaction of customary closing conditions. Together with its existing cash and cash equivalents and marketable securities, C4T intends to use the net proceeds of the offering to primarily fund its ongoing and planned clinical trials of cemsidomide, other research and development activities, and for working capital and general corporate purposes. Jefferies, TD Cowen and Evercore ISI are acting as book-running managers for the offering. The securities were offered by C4T pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC) on October 31, 2024 and declared effective by the SEC on November 13, 2024 (File No. 333-282933). The prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at TDManualrequest@broadridge.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering will be made only by means of the prospectus supplement and the accompanying prospectus. About C4 TherapeuticsC4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the timing of the closing of the offering, the anticipated use of proceeds from the offering and the potential for any future proceeds to C4T from the exercise of the Class A and Class B Warrants and pre-funded warrants. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in C4T’s most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q and in its subsequent filings filed with the Securities and Exchange Commission, including the prospectus supplement, accompanying prospectus and any free writing prospectus relating to the offering. All forward-looking statements contained in this press release speak only as of the date on which they were made. C4T undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts:Investors:Courtney SolbergAssociate Director, Investor RelationsCSolberg@c4therapeutics.com Media:Loraine Spreen Senior Director, Corporate Communications & Patient Advocacy LSpreen@c4therapeutics.com

Phase 1

01 Oct 2025

·ir.c4therapeutics.com

C4 Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Pfizer for the Combination of Cemsidomide and Elranatamab for the Treatment of Relapsed/Refractory Multiple Myeloma

WATERTOWN, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. Under the terms of the agreement, Pfizer will supply elranatamab (ELREXFIO®), a B-cell maturation antigen CD3 targeted bispecific antibody (BCMAxCD3 bispecific), to C4T for its upcoming Phase 1b trial. The Phase 1b trial will evaluate the safety and tolerability of cemsidomide, an IKZF1/3 degrader, and dexamethasone in combination with elranatamab as a second line or later therapy for patients with multiple myeloma. This Phase 1b trial, which is expected to initiate in Q2 2026, will seek to establish an optimal dose for cemsidomide in combination with elranatamab. Under the terms of the agreement, Pfizer will supply elranatamab at no cost while C4T will sponsor and conduct the trial. “We look forward to initiating this trial to evaluate cemsidomide in combination with elranatamab in the hopes we can develop a new treatment regimen and potentially improve outcomes for multiple myeloma patients in earlier lines of therapy,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Our supply agreement with Pfizer creates an opportunity for cemsidomide to be combined with elranatamab, which is on the path to potentially becoming a standard of care BCMAxCD3 bispecific in a growing market.” Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to higher quality of responses. About C4 TherapeuticsC4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com. About CemsidomideCemsidomide is an investigational, orally bioavailable small-molecule degrader in clinical development for the treatment of relapsed/refractory multiple myeloma. Data from the Phase 1 trial, which has completed enrollment, demonstrate cemsidomide’s differentiated safety and tolerability profile and class-leading anti-myeloma activity that together support the potential for durable outcomes. Two clinical trials are planned to further evaluate cemsidomide in relapsed/refractory multiple myeloma: a Phase 2 single-arm registrational trial to evaluate cemsidomide in combination with dexamethasone, which is expected to initiate in Q1 2026; and a Phase 1b trial to evaluate the safety and tolerability of cemsidomide and dexamethasone in combination with elranatamab, which is expected to initiate in Q2 2026. Forward-Looking StatementsThis press release contains “forward-looking statements” of C4 Therapeutics, Inc., within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO® platform in the development of novel, selective, orally bioavailable BiDAC™ and MonoDAC™ degraders; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for and receipt of regulatory authorization related to clinical trials and other clinical development activities including clinical trial commencement or cohort initiation; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our ability to replicate interim or early-stage results from our clinical trials in the results obtained when those clinical trials are completed or when those therapies complete later-stage clinical trials; the potential timing for updates on our clinical and research programs; and our ability to fund our future operations. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing, advancement and conduct of preclinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that the results of preclinical studies and/or clinical trials will or will not be predictive of results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release and C4 Therapeutics undertakes no duty to update this information unless required by law. Contacts:Investors:Courtney SolbergAssociate Director, Investor RelationsCSolberg@c4therapeutics.com Media:Loraine SpreenSenior Director, Corporate Communications & Patient AdvocacyLSpreen@c4therapeutics.com

Phase 1License out/inPROTACs

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Elranatamab

External Link

KEGG	Wiki	ATC	Drug Bank
D12058	-	-	DB15395

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Pfizer Inc.	14 Aug 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	United States	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Japan	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Argentina	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Australia	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Belgium	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Brazil	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Canada	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Croatia	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Czechia	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Denmark	Pfizer Inc.	08 Feb 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Multiple Myeloma	-	Anti-BCMA (Teclistamab and Elranatamab)	fsxoafyhvm(ntonmfiads) = ttkmyugpok lbytndalxb (rmwjqhlsos ) View more	Positive	30 May 2025
				Anti-GPRC5D (Talquetamab)	fsxoafyhvm(ntonmfiads) = cefoiwdfgz lbytndalxb (rmwjqhlsos ) View more
NCT05623020 (MagnetisMM-6, ASCO2025)	Phase 3	Multiple Myeloma BCMA-CD3	37	Elranatamab + Daratumumab + Lenalidomide	eudawfvuhb(zdxkgfedfh) = 1 case of G2 ICANS was reported lhrkikiijg (ptdwegrzso ) View more	Positive	30 May 2025
BOSS program (ASCO2025)	Not Applicable	Multiple Myeloma LDH \| ferritin \| cytopenia	43	elranatamab (BOSS program)	imuolekcph(kgmvgzgfrc) = flujqafcbj hvzoqvkqzi (ainildiuoy ) View more	Positive	30 May 2025
				elranatamab (iSUD program)	imuolekcph(kgmvgzgfrc) = beuqxdzulz hvzoqvkqzi (ainildiuoy ) View more
NCT04649359 (MagnetisMM-3, ASCO2025)	Phase 2	Refractory Multiple Myeloma	47	ELRA 76 mg QW	iypsjfmtlx(blykznphdp) = 100% pts reported any grade treatment-emergent adverse events eawlqxirqv (luklrizupz ) View more	Positive	30 May 2025
NCT05623020 (MagnetisMM-6, EHA2025)	Phase 3	Multiple Myeloma	37	ELRANATAMAB + DARATUMUMAB + LENALIDOMIDE (EDR)	lwojrhkmdu(wsddzglhgg) = There was one G5 Candida pneumonia rzynyeuzuj (wekdkttqpn ) View more	Positive	14 May 2025
PB3004 (EHA2025)	Not Applicable	Cytokine Release Syndrome \| Infectious Diseases TP53 loss \| del(17p)	14	Elranatamab	xpcvtgcehu(lyxuzgrcba) = One patient died of multi-organ failure due to progressive myeloma and concomitant infection following a single cycle elranatamab kxitolhcft (wzgqmjygmi ) View more	-	14 May 2025
				Immunoglobulin replacement therapy
NCT04649359 (MagnetisMM-3, EHA2025)	Phase 2	Multiple Myeloma BCMA	184	Elranatamab	mzmtejyjwd(xjkprpbuyg): least square mean difference = -11.22 (95% CI, -19.48 to -2.9)	Positive	14 May 2025
				Physician’s choice of therapy
PF796 (EHA2025)	Phase 2	Multiple Myeloma	40	Elranatamab	oqxfhzqdxz(eyvmymaaxz) = nkytmpcczi shqcxdbzkk (hfedvgpxny, 59 - 89) View more	-	14 May 2025
NCT04649359 (MagnetisMM-3, EHA2025)	Phase 2	Refractory Multiple Myeloma	47	ELRANATAMAB (ELRA)	hezfgdymxq(saitbuzcev) = 100% of patients experienced any grade treatment-emergent adverse events yinmrrwmuk (qesgevuzki ) View more	Positive	14 May 2025
NCT04649359 (MagnetisMM-3, EHA2025)	Phase 2	Refractory Multiple Myeloma BCMA	123	Elranatamab arm	gthgeaanlr(zfrggnxrya) = mdwqhbhcwf hwjtimoxao (rkkgqtrcot, NE) View more	Positive	14 May 2025
				Elranatamab (RW cohort)	gthgeaanlr(zfrggnxrya) = ovxhvirjly hwjtimoxao (rkkgqtrcot, 4.44 - 9.46) View more

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