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 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

FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

FDA Approves Tepotinib for Metastatic NSCLC

On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read the FDA announcement.

Read Merck KGaA's announcement.

Posted 2/4/21

New FDA-Approved Indication for Crizotinib Capsules

The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for crizotinib (Xalkori^®, Pfizer) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic leukemia kinase-positive. 

Read the Full Prescribing Information.

Read the Press Release.

Posted 1/26/2021

FDA Approves Nivolumab + Cabozantinib for Advanced RCC

On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Read Bristol Myers Squibb's announcement.

Read the FDA announcement.

Posted 1/22/2021

FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

• Have positive results of direct SARS-CoV-2 viral testing
• Are 12-years-old or older
• Weigh at least 40 kilograms (about 88 pounds)
• Are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients. 

Read the FDA announcement. 

Posted 11/20/2020

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients. 

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL