Week of June 29

This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neurodegeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.

Oncology


  • FDA approved Roche’s Phesgo to treat early and metastatic HER2+ breast cancer. Phesgo is a subcutaneous injection of Perjeta and Herceptin. Link


  • The American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and Society of Urologic Oncology released new consensus guidelines for diagnosis and treatment for patients with advanced prostate cancer. Link


  • Roche launched its automated digital pathology algorithm, uPath PD-L1, to help improve the speed and accuracy of NSCLC diagnosis. Link


  • FDA approved priority review for Myovant Sciences’s NDA for relugolix in treating advanced prostate cancer. Link


  • Sunesis Pharma announced they are discontinuing its Phase 1b/2 trial for Vecabrutinib in relapsed/refractory chronic lymphocytic leukemia or other B-cell malignancy patients. While Vecabrutinib was safe, there was insufficient efficacy evidence in treating BTK-inhibitor-resistant B-cell malignancies. Link


  • FDA approved Karyopharm’s Xpovio to treat third-line relapsed/refractory diffuse large B-cell lymphoma. Xpovio was granted priority review and fast track designation. Link


  • FDA granted Epizyme’s Tazverik accelerated approval in two indications of follicular lymphoma. Link


CNS Disorders and Neurodegeneration


  • FDA granted Breakthrough Therapy designation to Axsome Therapeutics’s AXS-05 in treating Alzheimer’s disease agitation. Link


  • FDA issued a Complete Response Letter to Molecular Partners’s and Allergan’s Biologics License Application (BLA) for Abicipar pegol in treating neovascular (wet) age-related macular degeneration. The FDA cited that Abicipar pegol, an investigational DARPin therapy, had an unfavorable benefit-risk ratio in treating age-related macular degeneration. The companies plan to meet with the FDA before determining their next steps. Link


Technologies


After a second patient death, Audentes Therapeutics halted their gene therapy trial of AT132. Both patients with X-linked myotubular myopathy received a higher dose due to dosing being dependent on patients’ weight. An investigation is underway. Link


Industry and Corporate Developments


  • Poseida Therapeutics raised $110 million in its Series D financing round. The company uses proprietary gene engineering platform technologies to advance cell and gene therapeutics. Link


  • Indian drugmakers Cipla and Hetero Labs are developing a generic version of Gilead Sciences’ remdesivir. The generic will be priced at around $350-700 per treatment course which is considerably cheaper compared to Gilead Sciences’ cost of $3,120. Link


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