Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.
Researchers in Australia have developed new cancer cell line models for pediatric cancers with the lowest survival rates, with a focus on high-risk central nervous system tumors such as glioblastoma.
Convalife Pharmaceuticals Co. Ltd. acquired global rights to develop and commercialize a phosphoinositide 3-kinase (PI3K) β/δ inhibitor from Karus Therapeutics Ltd.
Convalife Pharmaceuticals Co. Ltd. acquired global rights to develop and commercialize a phosphoinositide 3-kinase (PI3K) β/δ inhibitor from Karus Therapeutics Ltd.
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
By cataloging protein-protein interactions in cell lines, and combining their results with in vivo studies as well as publicly available data, scientists have defined new interactions that could be used diagnostically, and/or harnessed, for well-studied cancer drivers and more obscure proteins alike.
Companion diagnostics-focused Celcuity Inc. CEO Brian Sullivan said the deal with Pfizer Inc. for rights to pan-PI3K/mTOR inhibitor gedatolisib was “an organically developed opportunity, because of the research we had done on gedatolisib” in the course of investigating PI3K inhibitors. “We hadn’t shifted our strategy and said, ‘Oh, let’s start in-licensing drugs.’”
Arriving at MEI Pharma Inc.’s deal with Kyowa Kirin Co. Ltd., focused on phase II-stage ME-401 for B-cell malignancies, was a competitive process that brought large and midsized pharma bidders to the table, MEI Chief Operating Officer David Urso said, but the terms proposed by suitors tended to “look a lot the same.”