Radium Ra-223 Dichloride

Growth in clinic sites, patients treated for prostate and neuroendocrine cancers FORT MYERS, Fla., April 2, 2025 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) continues to expand the availability of life-changing and life-saving radiopharmaceutical therapies that are benefiting a growing number of cancer patients. FCS now offers three FDA-approved drugs, Pluvicto™, Xofigo® and LUTATHERA™ (Radium-223 dichloride), at 14 clinic sites across its statewide network with plans to add one more site in Wesley Chapel by year-end. The number of patients and treatments administered for these cutting-edge therapies has more than doubled in the last three years due to growing availability and favorable outcomes. Continue Reading Florida Cancer Specialists & Research Institute has experienced significant growth in its radiopharmaceutical therapy by expanding its availability to patients, now in 14 locations throughout the statewide practice. FCS' Radiopharmaceutical Therapy (RPT) program launched in 2022 as the first oncology provider in Palm Beach County to offer Pluvicto™ and has since treated nearly 400 patients with over 1,000 infusions. The statewide practice has also seen similar growth in Lutathera and Xofigo patient visits over the past three years as it has broadened availability for those therapies. "Radiopharmaceutical therapy is an increasingly promising cancer treatment option for patients with certain late-stage or recurrent cancers who have had limited success with prior therapies," said FCS Director of Radiation Oncology Sachin Kamath, MD. "At FCS we have the specialized clinical expertise, capabilities and technologies required to ensure safe and effective administration practices to the highest standards." With RPT, a radioactive isotope is attached to a molecule and injected into the bloodstream intravenously to deliver a microscopic amount of radiation directly to tumor cells—killing or damaging them with minimal side effects and harm to surrounding healthy tissue. Due to their radioactive properties, these drugs must be administered in a clinic or facility where healthcare providers are trained and equipped to give radiation therapy. "FCS continues to outpace what is typical for a community oncology provider, said FCS President & Managing Physician Lucio N. Gordan, MD. "This program is further demonstration of our ongoing commitment to providing our patients with the most advanced and promising precision medicine options." FCS offers Pluvicto™ and Xofigo® (Radium-223 dichloride) for the treatment of late-stage (metastatic) castration-resistant prostate cancer and LUTATHERA®, the first and only approved radiation treatment for adults with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that can grow in the pancreas or other areas of the stomach, small intestine, rectum, colon or appendix. Background: Prostate cancer is the most common cancer among American men, after skin cancer, and the leading cause of cancer death. Nearly 314,000 American men will be diagnosed with prostate cancer in 2025. Approximately 10 – 20% of cases are classified as castration resistant and a portion of those are metastatic. Although rare, approximately 12,000 Americans will be diagnosed with GEP-NETs in 2025, and the numbers are rising. Additionally, the incidence of GEP-NETs in the U.S. has increased in many organ sites in the past two decades, according to published studies. A research letter reported in JAMA Oncology found that between 2001 – 2020, overall incidence increased nearly four percent with increases seen in most organs. Pluvicto™ is the first targeted radioligand therapy approved by the U.S. Food & Drug Administration (FDA) to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC). This therapy is available to eligible adult males whose prostate cancer has metastasized to other parts of the body. Last week, the U.S. Food & Drug Administration approved the use of Pluvicto in patients who have not previously undergone chemotherapy. In doing so, more patients will now have access to this revolutionary therapy. Xofigo® (Radium-223 dichloride) treats men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to the bones but not to other organs, who have already received Androgen Deprivation Therapy (APT). LUTATHERA® is the first and only approved radiation treatment for adults with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) that can grow in the pancreas or other areas of the stomach, small intestine, rectum, colon or appendix. FCS locations now offering RPT: "There has been enormous growth in the development of radiopharmaceuticals. FCS, in particular, is making significant progress in the theranostic space which combines diagnostic and therapeutic agents," adds FCS radiation oncologist Luis Carrascosa, MD. "More hope is on the horizon and FCS will continue to be on the forefront to ensure our patients are able to access personalized precision oncology close to home." Dr. Carrascosa, a board-certified radiation oncologist, provides clinical leadership and oversight for the RPT program across the statewide practice. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. 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iStock, Love Employee While Novartis and Bayer got there first, AstraZeneca, Bristol Myers Squibb and Eli Lilly are all vying to bring their radiopharmaceutical assets to a market projected to be worth over $13 billion by 2033. When the FDA approved a small and peculiar eight-amino acid peptide therapy in 2018, it also signed off on a field that today provides a precise and personalized approach to treating cancer. Novartis’ Lutathera belongs to a class called radiopharmaceuticals, which combines a radioactive substance and a biological agent into one therapeutic molecule. Lutathera carries lutetium-177, a beta-emitting isotope of lutetium that releases high-energy radiation as it degrades, in turn damaging a cancer cell’s DNA and ultimately leading to its death. Meanwhile, the drug’s eight-residue backbone allows it to specifically home in on subtype 2 somatostatin receptors, proteins typically highly expressed on specific types of cancer cells. This specific structure gives Lutathera—and radiotherapies more broadly—their characteristic precision. Radiopharmaceutical drugs “can generally shrink tumors effectively without causing much side effects,” Andrew Tsai, an analyst at Jefferies, told BioSpace in an email. The use of radioisotopes gives this modality its marked efficacy, Tsai continued, adding that these treatments might also lead to a more durable, longer-lasting therapy. “Lethality of radiation on cancer is robust, and there is no resistance mechanism to the modality,” he explained. Of course, the use of radioactive agents, no matter how targeted, is still bound to cause some toxicity. According to Tsai, radiotherapies can lead to the accumulation of radiation in various organs, which “could limit the dosing potential” of the modality. There is also a limit to how precise radiopharmaceuticals can get, and they still sometimes lead to unintended off-target side effects such as dry mouth and alopecia. On a more practical level, supply constraints also pose a roadblock to radiopharmaceuticals. “Having access to radioisotope[s] has been rate limiting in many instances even for clinical trials,” Tsai said. Another barrier, he continued, is that the practice has yet to penetrate sufficiently into current medical practice; both patients and physicians remain uninformed or uncomfortable about the tech, and there is a need to improve their awareness. Here, BioSpace looks at the current state of radiopharmaceuticals through five leading players—Novartis, AstraZeneca, Bristol Myers Squibb, Eli Lilly and Bayer—including their strategic moves and key upcoming milestones in a space projected to be worth more than $13 billion by 2033. Novartis Seeks to Maintain Radiopharma Leadership Radiopharma assets: Lutathera, Pluvicto Novartis is the clear frontrunner in the radiopharmaceutical race. The Swiss drugmaker already has two commercial products on the market: Lutathera, indicated for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and Pluvicto, for metastatic castration-resistant prostate cancer (mCRPC). Compared with its competitors, Novartis has also fleshed out “industry-leading radioligand research and production sites” globally, Geoff Towle, vice president of the company’s radioligand therapy solid tumor strategy, told BioSpace in an email. Despite enjoying a comfortable lead, Novartis continues to strengthen its radiopharma portfolio. In May 2024, the company paid $1 billion to acquire Mariana Oncology and its promising pipeline, anchored by MC-339, an actinium-based therapy being studied in small cell lung cancer (SCLC). Novartis also recently launched two pivotal trials for the next-generation radiotherapy AAA817, which is under development for prostate cancer, Towle shared. Like Pluvicto, AAA817 targets the prostate-specific membrane antigen (PSMA) but instead carries an actinium-based payload, which could deliver higher potency . Aside from building out the pipeline, Novartis is also seeking to expand the indications for its current products. Pluvicto, for instance, is currently under review by the FDA for use in earlier-stage mCRPC, with a regulatory verdict expected in the first half of 2025 , Towle said. This approval, if granted, would allow the use of Pluvicto ahead of chemotherapy and would highlight the “potential for radioligand therapy to become an established pillar of cancer care,” he added. These strategic moves, according to Towle, place the company in a strong position to “realize the $10 billion business potential of our candidates in clinical trials or pre-clinical trials,” and bring radioligand therapies beyond prostate and neuroendocrine tumors to other areas of high unmet patient need, including breast and lung cancer. AstraZeneca Zeroes in on Radioconjugates Radiopharma assets: FPI-2265, AZD2068 AstraZeneca bought entry into the radiopharma market in March 2024, with the up to $2.4 billion acquisition of Fusion Pharmaceuticals. Despite being a relative newcomer to the space, AstraZeneca has set its sights high. In a company presentation last month, the pharma announced that radioconjugates are expected to be a strong driver of its business by 2030 and beyond. “Our aim is to build a substantial radioconjugate portfolio to offer treatment options for patients with a broad range of tumor types,” Puja Sapra, AstraZeneca’s senior vice president for biologics engineering and oncology target discovery, told BioSpace in an email. In particular, the pharma envisions that radioconjugates will complement existing radiation therapy and help reach other cancer types that have been difficult to treat. AstraZeneca’s radiopharma pipeline is anchored by FPI-2265—the centerpiece of the Fusion acquisition—which consists of a small molecule drug that targets PSMA and carries an actinium-225 radioisotope that can inflict irreparable damage to cancer cells. FPI-2265 is being assessed in the Phase II AlphaBreak study in patients with PSMA-positive mCRPC, with a readout expected in the second half of 2025, according to Sapra. AstraZeneca is also working on AZD2068, another radioconjugate from Fusion, designed to target cells expressing the EGFR and cMET markers. The asset is currently in a Phase I study for advanced solid tumors. Findings are expected in 2026 at the earliest, according to the pharma’s latest pipeline document. Aside from its pipeline, AstraZeneca is also working on “molecular imaging and computation pathology,” which according to Sapra would “enhance the delivery and monitoring” of radioconjugates. The end goal, she continued, is to “deliver the right treatment to the right patient.” BMS Leads the Way in Actinium-Based Radiotherapies Radiopharma assets: RYZ-101, RYZ-801 A few months ahead of AstraZeneca, Bristol Myers Squibb made a major radiopharma play in December 2023 with the acquisition of RayzeBio and its actinium-225-based platform for $4.1 billion. “RayzeBio is pioneering the use of Actinium-225,” which is an alpha-emitting radioisotope, Ben Hickey, the company’s president under BMS, told BioSpace in an email. “We believe alpha-emitting isotopes represent the next generation of therapeutic radionucleotides due to their higher potency as compared to beta-emitting isotopes.” Novartis’ Lutathera and Pluvicto carry beta-emitting lutetium-177. With the RayzeBio acquisition, BMS gained ownership of the biotech’s lead asset RYZ-101, which targets somatostatin receptor type 2, a protein commonly expressed on certain solid tumors. BMS is running three clinical trials for RYZ-101: A Phase III study for GEP-NETs and Phase I studies in unresectable metastatic breast cancer and extensive-stage SCLC. The SCLC study will read out later this year , while pivotal data for GEP-NETs are expected in 2026, according to Hickey. “If successful, we believe RYZ101 could be the first [actinium-255-based radiopharmaceutical therapy] approved In the U.S.” BMS is also advancing RYZ-801 , which consists of a proprietary peptide bound to an actinium-225 radioactive payload. RYZ-801, which targets the GPC3 protein, entered the clinic late last year for hepatocellular carcinoma, with enrollment currently ongoing, according to Hickey. Aside from these two clinical assets, the acquisition of RayzeBio gave BMS what Hickey called an “IND-generating engine” that can produce “several therapeutic candidates in the coming years.” BMS currently has several preclinical programs ongoing, he said. Beyond beefing up its radiopharma pipeline, BMS is also building up manufacturing capabilities. Hickey said the pharma’s facility in Indianapolis “is now fully operational” and can contribute to clinical supply, while BMS works to ramp up the site to support commercial-scale operations. Eli Lilly Enters Radiopharma Space With Dealmaking Flurry Radiopharma asset: PNT2001 and PNT2002 Ahead of both BMS and AstraZeneca, Lilly entered the radiopharma arena in October 2023 with $1.4 billion to acquire Point Biopharma—a transaction that formally closed in December that year. Less than a year later, in May 2024, Lilly doubled down on radiopharma with an agreement with Aktis Oncology worth up to $1.1 billion. The deal gave Lilly access to the biotech’s proprietary discovery engine to develop novel radiotherapeutic assets against certain cancer targets. But Lilly wasn’t done. In July 2024, the company entered into another strategic alliance , this time with Radionetics Oncology, for $140 million upfront. The partners will work on radiotherapies targeting small-molecule G-protein coupled receptors for the treatment of various solid tumors. Under the deal, Lilly also has the exclusive right to acquire Radionetics for $1 billion. From the Point acquisition, Lilly gained ownership of the biotech’s lead asset PNT2002, a PSMA-targeted lutetium-177-based therapy being proposed for patients with mCRPC whose disease has progressed after hormonal treatment. A Phase III readout in December 2023 for PNT2002 was disappointing : The asset reduced the risk of death or disease progression by 29% versus androgen receptor blockage—an effect that met statistical significance but fell below what analysts had hoped for. Regulatory filings for PNT2002 are “pending,” according to Jefferies’ Tsai. Lilly has other radiopharma bets in the clinic, including PNT2001, which targets the PSMA protein and carries a 225-actinium radioisotope payload. The asset is currently in Phase I development for prostate cancer. According to a Feb. 7 Jefferies note, Lilly also has a preclinical radiopharma candidate that uses 225-actinium. Another, PNT2003, delivers lutetium-177 and targets the somatostatin receptor to address GEP-NETs. Bayer Builds Radiopharma Pipeline Beyond Xofigo Radiopharma assets: Xofigo, 225Ac-Pelgifatamab, 225Ac-PSMA-Trillium Aside from Novartis, the only other company on this list with an FDA-approved radiopharma asset is Bayer. Xofigo , a radium-223 dichloride radioactive drug, was cleared by the FDA in 2013 for the treatment of castration-resistant prostate cancer with symptomatic bone metastases and with no known visceral metastatic disease. Unlike Novartis’ Lutathera and Pluvicto, however, Xofigo does not include a targeting moiety. Instead, the drug takes advantage of radium’s chemistry, which allows it to bind to bone minerals, in turn helping localize the drug to sites of high bone turnover. Xofigo’s market performance has been underwhelming, peaking at €408 million in 2017 . Bayer did not report specific sales for Xofigo last year. But the pharma is attempting to carve out a space in today’s radiopharma space, inking a strategic collaboration with Bicycle Therapeutics in May 2023. For $45 million upfront and up to $1.7 billion in milestones, Bayer gained access to Bicycle’s proprietary peptides, which it will use to develop targeted radiotherapies for several undisclosed cancer targets. As per its pipeline page , Bayer has at least two clinical-stage radiopharmaceutical therapies in development: 225Ac-Pelgifatamab and 225Ac-PSMA-Trillium, both actinium-based candidates in early-stage studies for advanced prostate cancer.