FDA Approves Fam-Trastuzumab Deruxtecan-nxki for HER2-Positive Gastric Cancer

The U.S. Food and Drug Administration (FDA) approved AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s trastuzumab deruxtecan (Enhertu^®) for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Read press release. 

[Virtual Panel] MDT Approaches to Treating Unresectable Stage III NSCLC

Thursday, May 6
6:00 - 7:15 PM PST

Hosted by AstraZeneca, this virtual panel discussion will focus on multidisciplinary (MDT) approaches to treating patients with unresectable stage III NSCLC. 

Meet the Panelists:
Ronald Natale, MD
Director, Lung Cancer Clinical Research Program
Samuel Oschin Comprehensive Cancer Institute
Professor of Medicine, Division Hematology/Oncology
Cedars-Sinai Medical Center
Los Angeles, CA

Arya Amini, MD
Assistant Professor, Chief of Thoracic Radiotherapy
City of Hope National Medical Center
Duarte, CA

Jed Gorden, MD, FCCP
Director of Interventional Pulmonology; Director Center Lung Research in Honor of Wayne Gittinger
Department of Thoracic Surgery and Interventional Pulmonology
Swedish Cancer Institute
Seattle, WA

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

[Virtual Webcast] African American Experience in Multiple Myeloma

Thursday, May 13
3:00 - 4:00 PM PDT/6:00 - 7:00 PM EDT

Brought to you by Oncopeptides, this presentation will feature a panel of experts discussing key data around the African American Experience in Multiple Myeloma and strategies to remove disparities and barriers to care, followed by a Q&A session. This is not a promotional event—Pepaxto will not be discussed on this webinar.

REGISTER

Posted on 4/27/2021

FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Read the FDA announcement.

Read the BMS announcement.

Posted 4/16/2021

FDA Approves Idecabtagene Vicleucel for R/R Multiple Myeloma

On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Read the FDA announcement.

Read the Bristol Myers Squibb announcement.

Read the bluebird bio, Inc. announcement.

Posted 3/29/21

FDA Approves Trastuzumab-qyyp Biosimilar

The U.S. Food and Drug Administration approved the 150 mg single-dose vial of trastuzumab-qyyp (Trazimera^®, Pfizer)—a biosimilar to Herceptin^® (trastuzumab).

Read the full prescribing information.

Posted on 3/11/2021

FDA Approves Bevacizumab-bvzr for New Indication

The U.S. Food and Drug Administration approved the inclusion of epithelial ovarian, fallopian tube, and primary peritoneal cancer to the indications of bevacizumab-bvzr (Zirabev^®, Pfizer). 

Read the full prescribing information.

Posted on 3/11/2021

FDA Expands Lorlatinib Approval to Include ALK-Positive NSCLC

On March 3, 2021, the U.S. Food and Drug Administration (FDA) expanded lorlatinib's indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorlatinib is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Read Pfizer's announcement.

Posted 3/4/21

FDA Approves Melphalan Flufenamide for R/R MM

On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Read Oncopeptides' announcement.

Posted 3/1/21