FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

Read the FDA announcement.

Read Novartis' announcement.

Posted 11/1/2021

FDA Approves Pembrolizumab Combination for Cervical Cancer

On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. 

Read the FDA announcement.

Read Merck's announcement.

Posted 10/14/2021

FDA Approves Abemaciclib with Endocrine Therapy for Early Breast Cancer

On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test. 

Read the FDA announcement.

Read Eli Lilly and Company's announcement.

Posted 10/14/21

FDA Expands Cetuximab in Combination Label for Metastatic Colorectal Cancer

On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Read Eli Lilly's announcement.

Posted 9/29/2021

FDA Approves Cabozantinib for Locally Advanced or Metastatic DTC

On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.

Read the FDA announcement.

Read Exelixis' announcement.

Posted 9/20/2021

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

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 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

FDA Approves Levnatinib + Pembrolizumab for Advanced RCC

On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Read the FDA announcement.

Read the Eisai announcement.

Posted 8/16/2021

FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Read Merck's announcement.

Posted 7/27/2021

FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. 

Read the FDA announcement.

Read the Merck announcement.

Read the Eisai Inc. announcement. 

Posted 7/22/2021

FDA Approves Expanded Indication for Pembrolizumab for cSCC

Updated Data for Durvalumab

Durvalumab (Imfinzi^®, AstraZeneca) offers the best chance for long-term survival in a curative intent setting. This update comes after the post-hoc analysis of 5-year overall and progression-free survival data had been released for the PACIFIC trial, a large, Phase III, randomized, double-blind, placebo-controlled, multicenter study of 713 patients with unresectable Stage III NSCLC. The primary overall survival analysis was reported at 2 years (25.2 months median follow-up). For more information, click here. 

Posted 6/10/2021

FDA Approves Sotorasib for KRAS G12C-Mutated NSCLC

The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRAS^TM, Amgen) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib has received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Read press release.

Posted on 6/1/2021

FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

Read the FDA announcement.

Read the Bristol Myers Squibb announcement.

Posted 5/21/2021

Positive Phase 3 Cemiplimab Results in Advanced Cervical Cancer

On Wednesday, May 12, Regeneron Pharmaceuticals, Inc. and Sanofi announced the presentation of positive results from the Phase 3 trial investigating the PD-1 inhibitor cemiplimab (Libtayo^®) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.

The data were shared as part of a European Society for Medical Oncology Virtual Plenary and add to previously reported data showing an improvement in overall survival (OS) with Libtayo compared to chemotherapy. The data will form the basis of regulatory submissions in 2021.

Read the press release.

Posted on 5/12/2021

FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

The Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda^®, Merck) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.

Read the prescribing information and medication guide.

Posted on 4/30/2021