The FDA has required that Amgen compare its approved KRAS-targeted therapy sotorasib (Lumakras) 960-mg dose with a 240-mg dose as one of its accelerated approval post-marketing requirements, a paradigm-shifting event that signals new scrutiny around determining the labeled dose for targeted oncology drugs, which still follow outdated maximum tolerated dose (MTD) principles in cytotoxic agents.
The FDA’s Oncologic Drugs Advisory Committee will hold a public meeting from April 27 to 29, 2020, to reevaluate six treatments that were previously granted accelerated approval and have since reported results that failed to verify clinical benefit. The six indications to be discussed include atezolizumab (two indications), pembrolizumab (three indications), and nivolumab (one indication).
In June 2020, the US Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme), an oral EZH2 inhibitor for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL). Clinical Advances in Hematology & Oncology takes a closer look at this new treatment through a conversation with Dr. Connie Lee Batlevi from […]
Another win for Merck and Keytruda, as the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on PFS. The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx.
Based on monotherapy data from an open-label, multi-center, single-arm study of 105 adults with platinum-sensitive and platinum-resistant SCLC that progressed after platinum-based chemotherapy, the FDA granted accelerated approval to lurbinectedin (Zepzelca; Jazz Pharmaceuticals and PharmaMar).
Based on the results of an open-label trial, selpercatinib (Retevmo) becomes the first targeted therapy to be granted accelerated approval by the FDA for use in patients with cancer who have certain tumors that have an alteration (mutation or fusion) in the RET gene.