It’s not a good week to be Vinay Prasad.
Imfinzi (durvalumab) has been accepted and granted Priority Review by the FDA for the treatment of patients with resectable, early-stage, and locally advanced (stages 2, 3, 4a) gastric and gastroesophageal junction cancers.
In a move that will have direct impact on approval of cancer drugs, George Francis Tidmarsh, an oncologist and a longtime pharmaceutical executive, was named director of the FDA Center for Drug Evaluation and Research.
Laura LoomerVinay PrasadRight-wing activist Laura Loomer is demanding Vinay Prasad’s ouster from FDA, calling him a “saboteur” and “trojan [sic] horse” of the administration’s “Make America Healthy Again” initiative.
A report from the nonpartisan Congressional Budget Office said that proposed cuts at NIH could lead to a decrease in the number of new drugs that come to market in the next three decades.
In April, FDA Commissioner Marty Makary said that the presence of industry employees as members of FDA advisory committees “represents a cozy relationship” between FDA and the businesses it regulates.
FDA’s Oncology Center of Excellence issued an RFA to support U01 cooperative agreements for applied regulatory science research to evaluate cardiotoxicity of oncology therapeutics.
FDA July 23 extended the review period for the Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
FDA issued a Complete Response Letter regarding the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
FDA granted Breakthrough Therapy designation to elironrasib, a RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
