On September 27, the US Food and Drug Administration (FDA) granted traditional approval to Retevmo® (selpercatinib) (Eli Lilly and Company, lilly.com) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDAapproved test, who require systemic therapy.
On October 3, the FDA approved Opdivo® (nivolumab) (Bristol Myers Squibb Company, bms.com) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
On October 10, the FDA approved Itovebi® (inavolisib) (Genentech, Inc., gene.com) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor (EGFR) 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
On October 18, the FDA approved Vyloy® (zolbetuximab-clzb) (Astellas Pharma US, Inc., astellas.com), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinumcontaining chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human EGFR 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
On October 29, the FDA granted accelerated approval to Scemblix® (asciminib) (Novartis AG, novartis.com) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
On November 8, the FDA approved Aucatzyl® (obecabtagene autoleucel) (Autolus Inc., autolus.com), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Drugs in the News
The FDA granted fast track designation to VLS-1488 (Volastra Therapeutics, volastratx.com), an investigational KIF18A inhibitor for treating platinum-resistant high-grade serous ovarian cancer.
The FDA granted fast track designation to SMT112 (ivonescimab) (Summit Therapeutics, smmttx.com), a novel bispecific antibody, for use in combination with platinum-based chemotherapy in adult patients with locally advanced or metastatic NSCLC who have an EGFR mutation and have experienced disease progression after EGFR-tyrosine kinase inhibitor therapy.
The FDA granted fast track designation for LP-184 (STAR-001) (Lantern Pharma Inc., lanternpharma.com), an investigational drug candidate to treat glioblastoma.
HC-7366 (HiberCell Inc., hibercell.com), a GCN2-targeting agent, received fast track designation from the FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia.
The FDA granted orphan drug designation for MB-108 (Mustang, mustangbio.com), a herpes simplex virus type 1 oncolytic virus, for the treatment of malignant glioma.
The FDA granted orphan drug designation to LBL-034 (Nanjing Leads Biolabs, Co., leadsbiolabs.com), a humanized bispecific T-cell engaging antibody targeting both GPRC5D and CD3 for the treatment of multiple myeloma.
Devices and Assays in the News
The FDA approved Optune Lua (Novocure, novocure.com), a tumor treating fields device, for use in adult patients with metastatic NSCLC who are receiving PD-1/PD-L1 inhibitors or docetaxel and have experienced progression during or after treatment with a platinumbased chemotherapy regimen.
The FDA approved MI Cancer Seek™ (Caris Life Sciences, carislifesciences.com) for use as a companion diagnostic CDx to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes 1 pan-cancer and 5 tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is available for adults and pediatric patients, ages 1–22.
The FDA’s Center for Biologics Evaluation and Research granted breakthrough device designation for SeaStar Medical Holding Corporation’s (seastarmedical.com) celldirected Selective Cytopheretic Device to treat chronic systemic inflammation in end-stage renal disease patients who require chronic hemodialysis, also known as chronic dialysis.
The FDA approved Varipulse (Johnson & Johnson, jnj.com), a pulsed field ablation system, for a type of condition which causes abnormal heart rhythm.