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FDA Approvals, News & Updates

Tecartus, a Gene Therapy, Now Approved for Patients with Relapsed B-Cell Precursor Acute Lymphoblastic Leukemia
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 ›

Scemblix a New Oral Therapy Approved for Patients with Chronic Myeloid Leukemia
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 ›

Keytruda plus Chemotherapy FDA Approved for First-Line Treatment of Cervical 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. Read More ›

Keytruda FDA Approved for Adjuvant Treatment of Kidney Cancer
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 ›

Darzalex Faspro, Kyprolis, and Dexamethasone a New Combination Approved for Multiple Myeloma
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 ›

Verzenio First CDK4/6 Approved with Endocrine Therapy for Adjuvant Treatment of Early Breast Cancer
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 ›

FDA Approved Fyarro for Malignant Perivascular Epithelioid-Cell Tumor

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.

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Jemperli a New Immunotherapy Approved for All Patients with dMMR Solid Tumors
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 ›

Tecentriq First Immunotherapy Approved for Adjuvant Treatment of Patients with Early-Stage NSCLC and PD-L1 Expression
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 ›

Exkivity Second FDA-Approved Oral Targeted Therapy for Patients with Metastatic NSCLC and EGFR Exon 20 Insertion Mutations
On September 15, 2021, the FDA approved Exkivity (mobocertinib) capsules, an oral kinase inhibitor, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy, a cancer with few treatment options. Read More ›

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