FDA Approvals, News & Updates
In January 2022, the FDA approved Kimmtrak (tebentafusp-tebn), a novel type of immunotherapy, for the treatment of adults with advanced or spreading uveal melanoma, a rare and aggressive type of melanoma that affects the eye. Kimmtrak is the first drug approved for this type of melanoma. Read More ›
In October 2021, the FDA approved a second indication for Tecartus (brexucabtagene autoleucel), a novel, genetically modified CAR T-cell therapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read More ›
In October 2021, the FDA approved Scemblix (asciminib) for patients with chronic-phase Ph-positive chronic myeloid leukemia (CML) or CML associated with T315I mutation. Scemblix is a new type of drug that may improve outcomes over other therapies for some patients with CML. Read More ›
In October 2021, the FDA approved the immunotherapy Keytruda (pembrolizumab), in combination with chemotherapy and with or without Avastin (bevacizumab), for patients with persistent, recurrent, or metastatic cervical cancer and PD-L1 expression. Read More ›
In November 2021, the FDA approved a new indication for the immunotherapy Keytruda (pembrolizumab) for adjuvant treatment (after surgery) of patients with renal-cell carcinoma that is at intermediate-high or high risk for recurrence. Read More ›
In November 2021, the FDA approved the combination of subcutaneous Darzalex Faspro (daratumumab and hyaluronidase) plus Kyprolis (carfilzomib) and dexamethasone for adults with relapsed or refractory multiple myeloma who have received previous therapy. Read More ›
In October 2021, the FDA approved the combination of Verzenio (abemaciclib), a CDK 4/6 inhibitor, plus endocrine therapy for adjuvant treatment (after surgery) of adults with HR-positive, HER2-negative, node-positive, early breast cancer that is at high risk of recurrence. Read More ›
On November 22, 2021, the FDA approved Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound); from Aadi Bioscience) for adults with locally advanced, unresectable or metastatic malignant perivascular epithelioid-cell tumor (PEComa), a rare type of mesenchymal tumors that can occur in any part of the body.
Read More ›On August 17, 2021, the FDA accelerated the
approval of Jemperli (dostarlimab-gxly; from
GlaxoSmithKline) injection, an immunotherapy and
a PD-1 inhibitor, for the treatment of all adults with
recurrent (coming back) or advanced mismatch
repair-deficient (dMMR) solid tumors, including
lung cancer, that progressed during or after systemic
therapy and for whom there are no satisfactory alternative treatment options. Read More ›
On October 15, 2021, the FDA approved a new indication for Tecentriq (atezolizumab) for adjuvant (additional) treatment of patients with stage II-IIIA non–small-cell lung cancer and PD-L1 expression, after surgical removal of the tumor and chemotherapy. This is the first immunotherapy approved for patients with early-stage lung cancer. Read More ›