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FDA Approvals, News & Updates

Kimmtrak First Drug FDA Approved for Metastatic Uveal Melanoma
FDA Approvals, News & UpdatesMelanoma
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.
Tecartus, a Gene Therapy, Now Approved for Patients with Relapsed B-Cell Precursor Acute Lymphoblastic Leukemia
FDA Approvals, News & UpdatesLeukemia
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.
Scemblix a New Oral Therapy Approved for Patients with Chronic Myeloid Leukemia
FDA Approvals, News & UpdatesLeukemia
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.
Keytruda plus Chemotherapy FDA Approved for First-Line Treatment of Cervical Cancer
FDA Approvals, News & UpdatesCervical Cancer
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.
Keytruda FDA Approved for Adjuvant Treatment of Kidney Cancer
Kidney CancerFDA Approvals, News & Updates
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.
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