Pfizer/Coley lung cancer agent starts Phase III
This article was originally published in Pharmaceutical Approvals Monthly
Coley and partner Pfizer have initiated a Phase III program evaluating the toll-like receptor agonist PF-3512676 (formerly ProMune) for first-line treatment of advanced non-small cell lung cancer, Coley says Nov. 28. Two 800-patient studies are being conducted under an FDA special protocol assessment and will evaluate the drug in combination with current standard-of-care chemo regimens; the primary endpoint is overall survival. Pfizer and Coley entered into a development and commercialization agreement for PF-3512676 in March (Pharmaceutical Approvals Monthly April 2005, p. 26)...
You may also be interested in...
Pfizer to fund Phase III ProMune trials for lung cancer under licensing pact valued at up to $505 mil., plus royalties. Medicis gains Botox competitor in $2.8 bil. Inamed purchase. Baxter gets U.S. rights to Cangene WinRho SDF for bleeding disorder. More licensing deals in brief
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.