Talazoparib Tosylate

Today, a brief rundown of news involving Eli Lilly and Novartis, as well as updates from Astellas Pharma, Pfizer and Bolt Biotherapeutics that you may have missed.Patrik Jonsson will retire from Eli Lilly at the end of 2026, completing a 36-year run at the Indianapolis-based drugmaker. Jonsson started at Lilly as a sales representative in Sweden in 1990 and rose through the ranks to eventually lead the companys global pharmaceutical business, Lilly International. Once he steps down, Lillys U.S. and international divisions will combine into an entity called Lilly Global Markets and be headed by Ilya Yuffa, a Lilly executive vice president and head of global customer capabilities. The new structure will accelerate decision-making, increase scalability and help broaden access to medicines globally, Lilly said. Ben FidlerNovartis will take a $1.9 billion impairment charge after seeing an experimental drug it acquired in a $12 billion buyout of Avidity Biosciencesfail a late-stage trial in August. The Swiss drugmaker revealed the write-off in its latest quarterly earnings report Tuesday, which included sales figures that topped Wall Streets expectations and news that the company hiked its 2026 financial forecasts. Novartis is facing multiple key patent expirations in the near future and is looking to key drugs in its late-stage pipeline, like Aviditys del-desiran, to spur future growth. Though that drug fell short in a study in a rare muscle-wasting disease, the company hasnt given up on its approval chances. An open-label extension to that trial is ongoing, and executives told analysts Tuesday that they assume Novartis will need to run an additional Phase 3 study. Delilah AlvaradoAstellas Pharma has secured from Australian biotech Audax Biosciencesan option to license an experimental cancer immunotherapy nearing human testing. Called DAX-044, the therapy is an antibody-cytokine fusion designed to deliver the immune protein IL-12 into cancer cells. In a statement, Astellas said DAX-044 has best-in-class potential. The deal involves $285 million in up front and future option payments, and could include another $1.05 billion in additional consideration if certain milestones are met. Phase 1 testing should begin in 2027, Astellas said. Ben FidlerThe Food and Drug Administration has expanded use of a two-drug regimen involving Pfizers cancer medicine Talzenna and the hormone therapy Xtandi.The combination was first approved in 2023 for certain patients with metastatic prostate cancer whod stopped responding to hormone treatments. The new clearance makes treatment available earlier, when the benefits might be greater. The approval was based on study results showing the regimen cut the risk of cancer progression or death by more than half when compared to Xtandi and a placebo. Delilah AlvaradoPrana Therapeutics is going public through a reverse merger with Bolt Biotherapeutics. The stock-for-stock deal announced Friday came alongside a $120 million private financing thatll help fund the company through 2027 and into the following year. Prana is developing multi-pronged antibody drugs designed to last longer and require infrequent dosing. Its lead asset, PRA-216, zeroes in on the proteins TSLP and IL-4R and is in mid-stage testing for atopic dermatitis, asthma and chronic obstructive pulmonary disease. A second prospect is also being developed for atopic dermatitis but aims at a different target, IL-31. Data from first-in-human studies are expected next year. Delilah Alvarado '

The FDA label expansion of Talzenna-Xtandi brings the combination therapy into an earlier line within the prostate cancer treatment paradigm. Credit: Jo Panuwat D / Shutterstock.com. The US Food and Drug Administration (FDA) has awarded a label expansion to Pfizer’s targeted oncology combination of Talzenna (talazoparib) and Xtandi (enzalutamide) – expanding its reach to earlier lines of treatment for prostate cancer patients. Following this approval, the PARP and androgen receptor inhibitor combination will become available to patients with metastatic hormone-sensitive prostate cancer – specifically those whose disease is androgen pathway modulation-naïve or sensitive and harbours BRCA or non-BRCA homologous recombination repair gene mutations. This broadens the role of Talzenna-Xtandi from its original approval back in 2023, when the FDA greenlit the drug for use in patients with metastatic castration-resistant prostate cancer (mCRPC) with HRR gene mutations. The approval for Talzenna-Xtandi is based on the positive outcomes of the Phase III TALAPRO-3 study (NCT04821622), in which the combination cut the risk of radiographic progression or death by 52% versus placebo plus Xtandi, while maintaining a manageable safety profile. Talzenna-Xtandi’s approval comes as the 2026 European Society of Medical Oncology (ESMO) Congress, held in Madrid from 23 to 27 October, draws to a close. At the conference, researchers presented several prostate cancer readouts . With a new indication in the bag, Pfizer will become available to a new patient population, who have traditionally had limited treatment options to turn to. Currently, researchers estimate that around one in four patients with metastatic androgen pathway modulation-naïve or sensitive prostate cancer harbour HRR gene mutations. According to Pfizer’s chief US commercial officer and EVP, Aamir Malik, Talzenna-Xtandi will provide a new option “at a stage where it may have a greater impact to delay progression”. Meanwhile, TALAPRO-3 lead investigator, Neeraj Agarwal, noted that the expanded approval of Talzenna-Xtandi will be a “critical advancement” for newly diagnosed patients with metastatic, HRR gene mutated prostate cancer, who he says generally face a worse prognosis. “In the TALAPRO-3 trial, clinical benefits were consistent for patients with BRCA and non-BRCA HRR gene mutations, addressing a long-standing unmet need,” Agarwal commented. CDx at the cornerstone of the personalised medicine revolution Another key finding from TALAPRO-3, Agarwal noted, was the benefit of performing biomarker testing to effectively tailor a patient’s treatment pathway at the time of diagnosis. He raises this point as the cancer treatment paradigm undergoes a fundamental shift towards personalised medicine, with companion diagnostic (CDx) testing becoming increasingly revered as a method to provide tailored treatment that suits the unique characteristics of a patient’s disease. Previously, Andrew Thompson, GlobalData Healthcare’s director of therapy research and analysis in medical devices, told Medical Device Network , sister publication to Pharmaceutical Technology, that recent changes in European regulation may signify the market’s move into a CDx adoption model more akin to that in the US, as the FDA pushes for the co-approval of drugs and diagnostics so a branded test can drive reimbursement of a therapy. Meanwhile, Karan Arora, SVP of advanced assays, srtificial intelligence (AI), and pharma services at Leica Biosystems previously highlighted that advancements in genomics, digital pathology, and AI-driven analytics were key pieces of the puzzle to allow for rapid and accurate biomarker identification.