FDA News

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.

The FDA has approved the first targeted therapy for patients with HER2-low metastatic breast cancer.

Based on data from the DESTINY-Breast04 trial, the FDA has granted a priority review designation for the supplemental biologics license application for fam-trastuzumab deruxtecan-nxki.

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 (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.

The FDA has approved crizotinib as a therapeutic option for patients with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors.

The FDA has approved lisocabtagene maraleucel as a second-line treatment for patients with relapsed or refractory large B-cell lymphoma.

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.

Tisagenlecleucel received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

Ivosidenib plus azacitidine received FDA approval for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) harboring IDH1 mutations.

Azacitidine (Vidaza) is now FDA approved for pediatric patients with newly diagnosed myelomonocytic leukemia.

Fam-trastuzumab deruxtecan-nxki is now an FDA-approved regimen for the treatment of patients with unresectable or metastatic HER2-positive breast cancer.

Axicabtagene ciloleucel is now FDA-approved for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

Lutetium-177-PSMA-617 is now FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer who have already received androgen receptor pathway inhibition and taxane-based chemotherapy.

The doublet regimen of relatlimab/nivolumab has been approved for adults with unresectable or metastatic melanoma.

Olaparib is now FDA approved for patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer and who have already undergone chemotherapy before or after surgery.

Nivolumab combined with chemotherapy is now approved in the resectable non–small cell lung cancer setting.

The FDA has approved pacritinib for patients with cytopenic myelofibrosis and severe thrombocytopenia.

Newly FDA-approved ciltacabtagene autoleucel was found to induce an objective response rate of 98% in patients with relapsed/refractory multiple myeloma.

Adagrasib is currently being considered for approval as a treatment option for previously treated patients with KRAS G12C-mutated non-small cell lung cancer.

The FDA set the Under the Prescription Drug User Fee Act date for June 24, 2022.

Tebentafusp is now the first FDA-approved therapy to treat unresectable or metastatic uveal melanoma.

Abatacept is now available for use in combination with certain immunosuppressants to prevent moderate to severe acute-graft-versus-host disease for select patients who have received unrelated donor hematopoietic stem cell transplant.

Pembrolizumab has been approved for the adjuvant treatment of adults and pediatric patients with stage IIB or IIC melanoma who have underwent complete resection.

The FDA has approved the combination of rituximab plus chemotherapy to treat children aged between 6 months and 18 years who have advanced-stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).

The FDA approval of sirolimus protein-bound particles marks the first approved therapeutic option for patients with advanced PEComa.

Pembrolizumab represents the first immunotherapy approved to treat patients with renal cell carcinoma in the adjuvant setting.

Ropeginterferon alfa-2b-njft is now an FDA-approved drug for the treatment of polycythemia vera.

The new Cilta-Cel PDUFA decision date is February 28, 2022.

Parsaclisib has been granted a priority review for 3 indications that include relapsed or refractory follicular, marginal zone, and mantle cell lymphoma.