FDA Approves Nivolumab in Combination for Early-Stage NSCLC

FDA Approves Ciltacabtagene Autoleucel for R/R Multiple Myeloma

On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel for the treatment of adults with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Read Janssen's announcement.

Posted 3/1/2022

FDA Approves Rituximab + Chemotherapy for Pediatric Cancer Indications

On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. 

Read the FDA announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

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

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 Approves Brexucabtagene Autoleucel for R/R B-Cell Precursor ALL

On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

Read the FDA announcement.

Read Kite Pharma's announcement.

Posted 10/4/2021