Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications
Accelerated approval in epithelioid sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.
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Both Atlas and Foresite Capital announced new funds focused on start-ups. Also, Flagship launched Vesalius with $75m in initial funding, Innoviva sold $225m in notes, Hookipa priced a $75m follow-on offering and job cuts were revealed by Epizyme, Flexion, Deciphera and Gemini.
Lilly partners with Kumquat to discover small molecule IO drug. Kite, Appia Bio collaborate on allogeneic cell therapies. AstraZeneca and Regeneron pursue novel metabolic therapies targeting GPR75. Lexeo and Stelios merge to focus on gene therapies for rare cardiovascular indications.
US FDA reviewers recommended against accelerated approval of Epizyme’s tazemetostat for epithelioid sarcoma, finding the modest overall response rates were not substantial evidence of an improvement over available therapies; they were overruled by senior oncology review staff, who cited a unanimous ODAC endorsement and the regulatory flexibility encouraged for rare diseases.