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.
Author: RR
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.
RYTELO® (Imetelstat)
The FDA on June 6, 2024, approved RYTELO® an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk MyeloDysplastic Syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks, who have not responded to, or have lost response to, or are ineligible for Erythropoiesis-Stimulating Agents (ESAs). RYTELO® is a product of Geron Corporation.
BREYANZI® (Lisocabtagene maraleucel)
The FDA on May 30, 2024, approved BREYANZI® for adult patients with relapsed or refractory Mantle Cell Lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton Tyrosine Kinase Inhibitor (BTKi). BREYANZI® is a product of Juno Therapeutics, Inc.
RETEVMO® (Selpercatinib)
The FDA on May 29, 2024, granted accelerated approval to RETEVMO® (Selpercatinib) for pediatric patients two years of age and older with RET-altered metastatic thyroid cancer or solid tumors. RETEVMO® is a product of Eli Lilly and Company.
IMDELLTRA® (Tarlatamab-dlle)
The FDA on May 16, 2024, granted accelerated approval to IMDELLTRA® (Tarlatamab-dlle) (Imdelltra, Amgen, Inc.) for Extensive Stage Small Cell Lung Cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA® is a product of Amgen, Inc.