FDA Approvals, News & Updates

In September 2021, the FDA approved Cabometyx (cabozantinib) for the treatment of patients aged 12 years or older with locally advanced or metastatic thyroid cancer that progressed after VEGFR-targeted therapy who cannot use, or whose disease is not responding to, radioactive iodine therapy. Read More ›

In September, the FDA approved Tivdak (tisotumab vedotin) for the treatment of women with recurrent or metastatic cervical cancer that progressed during or after chemotherapy. This is the first tissue factor–directed antibody and microtubule inhibitor conjugate approved for women with advanced cervical cancer. Read More ›

In September 2021, the FDA approved Brukinsa oral capsules for adults with relapsed or refractory marginal-zone lymphoma. And in August, the FDA approved Brukinsa for adults with Waldenström’s macroglobulinemia, a rare, slow-growing type of non-Hodgkin lymphoma. Read More ›

In late May 2021, the FDA approved Truseltiq (infigratinib), a new targeted therapy, for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma and FGFR2 fusion or other rearrangement, as detected by an FDA-approved test. Read More ›

In July 2021, the FDA approved a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj), for use in combination with Pomalyst (pomalidomide) and dexamethasone, for adults with multiple myeloma who have received at least 1 previous line of therapy. Read More ›

In June 2021, the FDA approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for patients older than 1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by E. coli infection. Read More ›

In April 2021, the FDA approved Jemperli (dostarlimab-gxly) for patients with recurrent or advanced endometrial cancer and the biomarker mismatch repair-deficient. This is the first immunotherapy approved for patients with this type of cancer. Read More ›

In April 2021, the FDA approved Opdivo (nivolumab), for use with chemotherapy, as first-line treatment for patients with advanced or metastatic gastric cancer, including gastroesophageal junction cancer and esophageal adenocarcinoma. Read More ›

In May 2021, the FDA approved Keytruda (pembrolizumab), plus Herceptin and chemotherapy, for first-line treatment of locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the second immunotherapy approved for gastric cancer. Read More ›

In May 2021, the FDA approved Rybrevant (amivantamab-vmjw), an intravenous antibody that targets mutations in the EGFR and MET pathways, for the treatment of adults with non–small-cell lung cancer and EGFR exon 20 insertion mutations. This is the first drug approved for lung cancer with EGFR exon 20 insertion mutations. Read More ›