Oncology Newsfeed

FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations

On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with 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, whose disease has progressed on or after platinum-based chemotherapy.

Read the FDA announcement.

Read Takeda's announcement.

Posted 9/16/2021

FDA Grants Accelerated Approval to Zanubrutinib for R/R MZL

On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

Read the FDA announcement.

Read BeiGene's announcement.

Posted 9/15/2021

FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.

Read the FDA announcement.

Read BeiGene's announcement.

Posted 9/7/2021

FDA Approves Updated Pembrolizumab Indication for UC

FDA Approves Companion Diagnostic for IDH1-Mutated Cholangiocarcinoma

FDA Approves Ivosidenib for IDH1-Mutated Cholangiocarcinoma

On August 25, 2021, Servier Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved ivosidenib for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. 

Read the FDA announcement.

Read Servier Pharmaceuticals' announcement.

Posted 8/26/2021

New Permanent J-Code for Melphalan Flufenamide

Oncopeptides announces J-code J9247 for Pepaxto^® (melphalan flufenamide) injection, 1mg. This J-code will be effective on October 1, 2021.

FDA Approves Nivolumab for High-Risk Urothelial Carcinoma

On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab—240 mg every two weeks or 480 mg every four weeks—for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.

Read the FDA announcement.

Posted 8/20/2021

FDA Approves Dostarlimab-gxly for dMMR Recurrent or Advanced Solid Tumors

On August 17, 2021, the U.S. Food and Drug Administration (FDA) approved a second indication for dostarlimab-gxly for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors—as determined by an FDA-approved test—that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Read the FDA announcement.

Read GlaxoSmithKline's announcement.

Posted 8/18/2021

FDA Approves Belzutifan for von Hippel-Lindau Disease-Associted Tumors

On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

Read the FDA announcement.

Read the Merck announcement.

Posted 8/16/2021