Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Merck Files FDA Application for Keytruda/Chemotherapy Combo for Lung Cancer

XTALKS VITALS NEWS

Immunotherapy

This is the first time an application has been filed for regulatory approval for the company’s anti-PD-1 therapy to be used together with another cancer treatment.

Share this!

January 13, 2017 | by Sarah Hand, M.Sc.

This week, Merck submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for a drug combining Keytruda and chemotherapy for the treatment of metastatic or advanced non-squamous non-small cell lung cancer (NSCLC). This is the first time an application has been filed for regulatory approval for the company’s anti-PD-1 therapy to be used together with another cancer treatment.

The FDA granted Merck Priority Review, which should expedite the approval process. Merck is hoping that the Keytruda/chemotherapy combo is approved for the first-line treatment of lung cancer patients, regardless of whether they overexpress the immune checkpoint protein, PD-L1.



“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “Keytruda, in combination with chemotherapy, has shown promise versus chemotherapy alone in the first-line treatment of non-squamous metastatic non-small cell lung cancer, regardless of PD-L1 levels. If approved, this could be the first regimen combining chemotherapy with an immuno-oncology agent for patients with advanced non-small cell lung cancer.”

Keytruda is currently approved as a monotherapy for the first-line treatment of metastatic NSCLC in patients who show tumor expression of PD-L1. To be eligible for treatment with Keytruda, these patients must also have previously received platinum-containing chemotherapy and experienced disease progression.

About 85 percent of all cases of lung cancer are diagnosed as NSCLC, making it the most common form of the disease. Keytruda is an immunotherapy drug designed to strengthen the body’s immune system to both detect and destroy tumor cells. Along with its indication for lung cancer, Keytruda is also approved to treat melanoma, as well as head and neck squamous cell carcinoma.


Keywords: FDA, Lung Cancer, Immunotherapy


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Lavazza Acquires Controlling Stake in Canada’s Kicking Horse Coffee

May 26, 2017 - Italian coffee company Lavazza, has secured an 80 percent equity stake in Canadian organic and fair-trade coffee company Kicking Horse Coffee, in a deal worth CAD$215 million.

Featured In: Food News


FDA First: Keytruda Approved for Cancer Treatment Based on Biomarker Alone

May 25, 2017 - For the first time, the FDA has approved a cancer treatment for solid tumors based on the presence of a biomarker, as opposed to specifying a tissue of origin.

Featured In: Biotech News


One Year of Medically Assisted Dying in Canada

May 25, 2017 - In June of 2016, the federal government of Canada passed legislation to legalize medically assisted dying.

Featured In: Life Science News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Top 5 Most Impactful Tweets in Life Sciences During the Last Week

REGISTER FOR THESE WEBINARS

EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider


Thermal Processing Systems for the Food Industry: A Guide to Selecting Thermal Equipment and Technology


Rare Disease & Orphan Drug Development: Cost-Efficient Trial Design to Minimize Cash Burn


eTMF Workflows: Active eTMF to Improve the Quality of Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.