The FDA on August 2, 2024, granted accelerated approval to TECELRA®, a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA® is a product of Adaptimmune, LLC.
Category: FDA Approvals
JEMPERLI® (Dostarlimab-gxly)
The FDA on August 1, 2024, approved JEMPERLI® with Carboplatin and Paclitaxel, followed by single-agent JEMPERLI®, for adult patients with primary advanced or recurrent Endometrial cancer. JEMPERLI® is a product of GSK.
DARZALEX FASPRO® (Daratumumab and hyaluronidase-fihj)
The FDA on July 30, 2024, approved DARZALEX FASPRO® in combination with Bortezomib, Lenalidomide, and Dexamethasone for induction and consolidation in patients with newly diagnosed Multiple Myeloma who are eligible for Autologous Stem Cell Transplant (ASCT). DARZALEX FASPRO® is a product of Janssen Research & Development, LLC.
EPKINLY® (Epcoritamab-bysp)
The FDA on June 26, 2024, granted accelerated approval to EPKINLY®, a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. EPKINLY® is a product of Genmab US, Inc.
KRAZATI® (Adagrasib)
The FDA on June 21, 2024, granted accelerated approval to KRAZATI® (Adagrasib) plus Cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic ColoRectal Cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-based chemotherapy. KRAZATI® is a product of Mirati Therapeutics, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 17, 2024, approved KEYTRUDA® with Carboplatin and Paclitaxel, followed by single-agent KEYTRUDA®, for adult patients with primary advanced or recurrent Endometrial carcinoma. KEYTRUDA® is a product of Merck & Co., Inc.
BLINCYTO® (Blinatumomab)
The FDA on June 14, 2024, approved BLINCYTO® for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-Cell Precursor Acute Lymphoblastic Leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. BLINCYTO® is a product of Amgen Inc.
IMFINZI® (Durvalumab)
The FDA on June 14, 2024, approved IMFINZI® with Carboplatin plus Paclitaxel followed by single-agent Durvalumab for adult patients with primary advanced or recurrent Endometrial cancer that is MisMatch Repair deficient (dMMR). IMFINZI® is a product of AstraZeneca UK Limited.
AUGTYRO® (Repotrectinib)
The FDA on June 13, 2024, granted accelerated approval to AUGTYRO® for adult and pediatric patients 12 years and older with solid tumors that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. AUGTYRO® is a product of Bristol-Myers Squibb Company.
RETEVMO® (Selpercatinib)
The FDA on June 12, 2024, granted traditional approval to RETEVMO® for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). RETEVMO® is a product of Eli Lilly and Company.