Latest News & Updates
FDA Approves Teclistamab in Combination With Daratumumab Hyaluronidase-Fihj for Relapsed or Refractory Multiple Myeloma
March 6, 2026
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Read More
FDA Grants Accelerated Approval to Zongertinib for Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer
March 5, 2026
On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized 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 Teclistamab in Combination With Daratumumab Hyaluronidase-Fihj for Relapsed or Refractory Multiple Myeloma
March 6, 2026
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. Read More
FDA Grants Accelerated Approval to Zongertinib for Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer
March 5, 2026
On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized 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…
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