Latest News & Updates
FDA Approves Acalabrutinib With Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
February 26, 2026
On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600E Mutation
February 26, 2026
On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated…
FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
February 10, 2026
On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test,…
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
December 13, 2025
On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
FDA Approves Acalabrutinib With Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
February 26, 2026
On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600E Mutation
February 26, 2026
On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. Encorafenib received accelerated…
FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
February 10, 2026
On February 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test,…
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
December 17, 2025
On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).
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