Abemaciclib Indication Expands to Include HR+, HER2–, Node+, High-Risk, Early Breast Cancer
March 3rd 2023Abemaciclib, in combination with endocrine therapy, had been approved as an adjuvant treatment for patients with high-risk, hormone receptor–positive, HER2-negative, node-positive, early breast cancer.
ODAC Votes To Continue Dostarlimab Research in dMMR/MSI-H Locally Advanced Rectal Cancer
February 12th 2023In an 8 to 5 vote, ODAC voted in support of launching 2 single-arm trials seeking to characterize the risk-benefit profile of dostarlimab for patients with dMMR/MSI-H locally advanced rectal cancer.
FDA Approves Oral SERD Elacestrant for ESR1-Mutant ER+, HER2– Metastatic Breast Cancer
January 27th 2023The FDA has granted an accelerated approval to elacestrant (Orserdu) for the treatment of patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer following at least 1 prior lines of endocrine therapy.
FDA Grants Pirtobrutinib Accelerated Approval for Relapsed/Refractory MCL
January 27th 2023Pirtobrutinib has been approved for patients with mantle cell lymphoma. The prescribing label comes with warnings for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity.
FDA Approves Zanubrutinib for CLL/SLL
January 19th 2023The FDA has approved zanubrutinib for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The prescribing label comes with warnings for hemorrhage, infections, cytopenias, second primary malignancies, and cardiac arrythmias.
Tucatinib and Trastuzumab Combination Gains FDA Approval for RAS Wild-Type HER2+ mCRC
January 19th 2023The FDA has granted accelerated approval to tucatinib and trastuzumab for RAS wild-type, HER2-positive metastatic colorectal cancer. The prescribing information includes warnings for diarrhea and hepatotoxicity.
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.