FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021

Do Good Initiative: Share Your Insights!

As part of Breast Cancer Awareness month, Sanofi has launched a "Do Good" initiative where treatment insights will be gathered from healthcare providers through a brief survey. Once completed by a breast cancer treating professional, a $50 donation will be made by Sanofi to a patient advocacy group that supports underserved metastatic breast cancer patients. To greater the impact, Sanofi will match the donation made on behalf of the professional, which we believe will deliver more Good & further help underserved breast cancer patients.

Please take a moment to complete the survey and share your insights.

Complete Survey

Posted on 11/15/2021

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

Updated Prescribing Information for Neratinib Tablets

Learn about dosing options and the new 133-tablet bottle for your patients starting treatment with neratinib tablets (Nerlynx, Puma Biotechnology).

View full prescribing information. 

Posted on 9/14/2021

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