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.
Category: FDA Approvals
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.
BALVERSA® (Erdafitinib)
The FDA on January 19, 2024, approved BALVERSA® for adult patients with locally advanced or metastatic Urothelial Carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. BALVERSA® is a product of Janssen Biotech.
KEYTRUDA® (Pembrolizumab)
The FDA on January 12, 2024, approved KEYTRUDA® (Pembrolizumab) with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA Cervical cancer. KEYTRUDA® is a product of Merck.