Adagrasib Receives Accelerated Approval for KRAS G12C Mutated NSCLCDecember 13th 2022
Adagrasib 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 LeukemiaDecember 2nd 2022
The 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 PatientsNovember 16th 2022
The 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 MyelomaOctober 27th 2022
Patients 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 HCCOctober 24th 2022
The 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 Approves Futibatinib for Pretreated, Advanced or Metastatic Intrahepatic Cholangiocarcinoma with FGFR2 RearrangementsOctober 5th 2022
Futibatinib is now approved to treat patients with previously treated unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. The agent comes with warnings for ocular toxicities, and hyperphosphatemia and soft tissue mineralization.
FDA Approves Eflapegrastim to Decrease Risk of Infection in Patients Receiving Cytotoxic ChemotherapySeptember 22nd 2022
The FDA has approved eflapegrastim to treat febrile neutropenia. The agent should be administered 24 hours following cytotoxic chemotherapy. It comes with warnings for fatal splenic rupture, acute respiratory distress syndrome, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, and myelodysplastic syndrome.
Durvalumab Plus Gemcitabine/Cisplatin Approved by the FDA for Advanced or Metastatic Biliary Tract CancersSeptember 2nd 2022
The FDA has approved durvalumab for patients with advanced or metastatic biliary tract cancers. The immunotherapy comes with warnings for immune-related adverse events and infusion reactions.
FDA Gives Pemigatinib Greenlight for FGFR1 Rearranged Myeloid/Lymphoid NeoplasmsAugust 26th 2022
Pemigatinib 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 NSCLCAugust 12th 2022
The 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 NSCLCAugust 11th 2022
The 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 SituAugust 10th 2022
A 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 HSCTAugust 7th 2022
The 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 ApplicationsAugust 6th 2022
The 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 LymphomaJuly 22nd 2022
Mosunetuzumab, 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 CancerJuly 18th 2022
Mirvetuximab 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 TumorsJune 23rd 2022
The 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.