The FDA on March 22, 2024, approved ELAHERE® (Mirvetuximab soravtansine-gynx) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. ELAHERE® is a product of ImmunoGen, Inc. [now a part of AbbVie]).
Category: FDA Approvals
ICLUSIG® (Ponatinib)
The FDA on March 19, 2024, granted accelerated approval to ICLUSIG® (Ponatinib) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). ICLUSIG® is a product of Takeda Pharmaceuticals U.S.A., Inc.
BRUKINSA® (Zanubrutinib)
The FDA on March 7, 2024, granted accelerated approval to BRUKINSA® with Obinutuzumab for Relapsed or Refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. BRUKINSA® is a product of BeiGene USA, Inc.
OPDIVO® (Nivolumab)
The FDA on March 6, 2024, approved OPDIVO® in combination with Cisplatin and Gemcitabine for first-line treatment of adult patients with unresectable or metastatic Urothelial Carcinoma (UC). OPDIVO® is a product of Bristol-Myers Squibb Company.
BESPONSA® (Inotuzumab ozogamicin)
The FDA on March 6, 2024, approved BESPONSA® for pediatric patients 1 year and older with Relapsed or Refractory CD22-positive B-cell precursor Acute Lymphoblastic Leukemia (ALL). BESPONSA® is a product of Pfizer.
RYBREVANT® (Amivantamab-vmjw)
The FDA on March 1, 2024, approved RYBREVANT® (Amivantamab-vmjw) with Carboplatin and Pemetrexed for the first-line treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. RYBREVANT® is a product of Janssen Biotech, Inc.
TAGRISSO® (Osimertinib)
The FDA on February 16, 2024, approved TAGRISSO® with platinum-based chemotherapy for patients with Locally advanced or metastatic Non-Small Cell Lung Cancer (La/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. TAGRISSO® is a product of AstraZeneca Pharmaceuticals LP.
AMTAGVI® (Lifileucel)
The FDA on February 16, 2024, granted accelerated approval to AMTAGVI®, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. AMTAGVI® is a product of Iovance Biotherapeutics, Inc.
TEPMETKO® (Tepotinib)
The FDA on February 15, 2024, granted traditional approval to TEPMETKO® for adult patients with metastatic Non-Small Cell Lung Cancer (NSCLC) harboring Mesenchymal-Epithelial Transition (MET) exon 14 skipping alterations. TEPMETKO® is a product of EMD Serono, Inc.
ONIVYDE® (Irinotecan liposome)
The FDA on February 13, 2024, approved ONIVYDE® (Irinotecan liposome) with Oxaliplatin, Fluorouracil, and Leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. ONIVYDE® is a product of Ipsen Biopharmaceuticals, Inc.