FDA News

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.

The FDA have granted an accelerated approval to acimibinib, which treats CML by binding to the ABL myristoyl pocket.

Atezolizumab is the first immunotherapy approved in the adjuvant setting to treat NSCLC.

Pembrolizumab is approved both in combination with chemotherapy, with or without bevacizumab, and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer.

Abemaciclib is the first and only FDA approved CDK4/6 inhibitor to treat HR-positive, HER2-negative high-risk early breast cancer.

Brexucabtagene autoleucel is now an FDA approved treatment options for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Cetuximab represents the first approved anti-EGFR antibody which, in combination with encorafenib, is now available to treat adults with pretreated metastatic CRC with a BRAF V600E mutation.

The FDA has granted cemiplimab-rwlc a priority review based on findings from the largest to-date, randomized clinical trial in advanced cervical cancer.

The FDA has approved ruxolitinib to treat adults with steroid-refractory chronic graft-versus-host disease.

The FDA approved tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The FDA has green lit mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with an EGFR exon 20 insertion mutation.

Zanubrutinib received an accelerated approval for the indication of adults with marginal zone lymphoma with at least 1 prior treatment with an anti-CD20-based therapy.

Zanubrutinib (Brukinsa) is now FDA approved for the treatment of adults with Waldenström Macroglobulinemia.

Pembrolizumab has been granted full approval as a first-line treatment for a select population of patients with bladder cancer.

The Food and Drug Administration approved adjuvant nivolumab to treat urothelial carcinoma in patients who are at high risk of recurrence after undergoing radical resection, irrespective of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

The regulatory decision is based on findings from collective data from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumor, non-endometrial cancer, cohort F of the ongoing phase 1 GARNET trial (NCT02715284).

Belzutifan, a hypoxia-inducible factor inhibitor, has been approved for treatment of adults with cancers related to von Hippel-Lindau disease.

The FDA has determined that more data are necessary to certify the clinical benefit of retifanlimab for the treatment of squamous cell carcinoma of the anal canal.

The FDA has approved the first immunotherapy, pembrolizumab (Keytruda), to treat patients with high-risk early-stage triple-negative breast cancer.

The FDA has approved belumosudil for the treatment of patients aged 12 years and older with chronic graft-versus-host disease following failure of at least 2 prior lines of therapy.