Adagrasib Receives Accelerated Approval for KRAS G12C Mutated NSCLC
December 13th 2022Adagrasib has received accelerated approval for KRAS G12C mutated non–small cell lung cancer. The prescribing label comes with warnings for gastrointestinal toxicities, QTC interval prolongation, hepatotoxicity, and interstitial lung disease.
Olutasidenib Approved for IDH1-Mutated Acute Myeloid Leukemia
December 2nd 2022The FDA has approved olutasidenib capsules to treat patients with relapsed or refractory acute myeloid leukemia with identified an IDH1-mutation. The label comes with a boxed warning for differentiation syndrome, and a warning for hepatotoxicity.
Brentuximab Vedotin Gets Green Light for High-Risk Hodgkin Lymphoma in Pediatric Patients
November 16th 2022The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients with classical Hodgkin lymphoma.
Teclistamab-cqyv Snags Accelerated Approval for Relapsed or Refractory Multiple Myeloma
October 27th 2022Patients with multiple myeloma who have already undergone 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, may now receive treatment with teclistamab-cqyv (Tecvayli).
FDA Approves Durvalumab in Combination with Tremelimumab for Unresectable HCC
October 24th 2022The combination of durvalumab and tremelimumab has been approved for patients with unresectable hepatocellular carcinoma. The combination comes with warnings for immune-related adverse events and infusion reactions.
FDA Gives Pemigatinib Greenlight for FGFR1 Rearranged Myeloid/Lymphoid Neoplasms
August 26th 2022Pemigatinib has received FDA approval for relapsed or refractory myeloid/lymphoid neoplasms and FGFR1 rearrangement. Patients receiving pemigatinib will require monitoring for ocular toxicities and high phosphate levels.
HER2-Directed Therapy, Trastuzumab Deruxtecan, Approved for Metastatic NSCLC
August 12th 2022The FDA has approved trastuzumab deruxtecan for patients with HER2-mutated non–small cell lung cancer after the DESTINY-Lung02 results demonstrated a 57% overall response rate with the agent. The drug comes with warning for interstitial lung disease, neutropenia, and left ventricular dysfunction.
Capmatinib Snags Full FDA Approval for MET Exon 14 Skipping NSCLC
August 11th 2022The FDA has granted capmatinib regular approval for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to MET exon 14 skipping. The drug comes with warning for pneumonitis, hepatotoxicity, and pancreatic toxicity.
N-803 BLA Undergoes Review For BCG-Unresponsive Non–Muscle Invasive Bladder Cancer in Situ
August 10th 2022A biologics license application for the IL-15 superagonist N-803 has been accepted and the agent will be reviewed for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.
FDA OKs Omidubicel Priority Review For Patients in Need of Allogeneic HSCT
August 7th 2022The biologics license application for omidubicel has been granted priority review and will be assessed as a potential treatment for patients with blood cancer who require allogeneic hematopoietic stem cell transplant.
FDA Schedules ODAC Meetings to Review Pending Drug Applications
August 6th 2022The FDA has scheduled 3 sessions for the Oncologic Drugs Advisory Committee to review updates on the new drug application for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide and duvelisib.
Mosunetuzumab Receives Priority Review Designation for Relapsed/Refractory Follicular Lymphoma
July 22nd 2022Mosunetuzumab, a CD20 and CD3 T-cell engaging bispecific antibody, received a priority review designation from the FDA for the treatment of patients with relapsed/refractory follicular lymphoma following at least 2 prior systemic therapies.
Mirvetuximab Soravtansine Is Under Priority Review for FRα-High, Platinum-Resistant Ovarian Cancer
July 18th 2022Mirvetuximab soravtansine (IMGN853) has been granted priority review by the FDA for the treatment of patients with FRα-high, platinum-resistant ovarian cancer who have previously received between 1 and 3 systemic therapies.
FDA Grants Accelerated Approval to Dabrafenib Plus Trametinib for BRAF V600E–Mutated Solid Tumors
June 23rd 2022The FDA approval of dabrafenib plus trametinib for BRAF V600E–mutated unresectable or metastatic solid tumors highlights a potential need for routine BRAF testing in clinical practice, experts say.