Assessment of clinical benefit in recent FDA accelerated approvals for cancer drugs
The process of accelerated approval by the US Food and Drug Administration (FDA) has been…
Browsing: FDA Approvals
Colorectal cancer gene implicated in broad range of solid tumours
A gene associated with colorectal cancer appears to also play a role in the development…
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx for adult patients…
FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig,…
FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications
On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw with carboplatin and pemetrexed…
FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma
On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib with…
FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer
On January 12, 2024, the Food and Drug Administration approved pembrolizumab with chemoradiotherapy (CRT) for patients…
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib for adults…
FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence
On November 16, 2023, the US Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma…
FDA amends pembrolizumab’s gastric cancer indication
On November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab with…