US FDA approves breakthrough drug as first-line treatment for lung cancer

October 26, 2016

An immunotherapy drug called pembrolizumab, which was extensively evaluated by University of California, Los Angeles (UCLA) cancer researcher Dr. Edward Garon, has been approved by the US Food & Drug Administration (FDA) as first-line treatment for non-small cell lung cancer (NSCLC).

As a first-line treatment, it means that the drug may be accessed by some patients without having to receive other treatments first, such as chemotherapy.

The FDA also expanded the approval of pembrolizumab to treat the majority of people with NSCLC who had received prior chemotherapy, greatly increasing the patient population that can benefit from the treatment.

Expressing his excitement regarding the expanded group of patients who can access the drug, Garon, whose clinical studies helped lead to today’s FDA approval, said: “What is particularly encouraging is that we are now able to select, based on features in the tumor, approximately a quarter of advanced lung cancer patients who can receive immunotherapy as their initial treatment. This will allow them to live longer while delaying, and in some cases potentially avoiding, the side effects of traditional chemotherapy.”

Pembrolizumab, marketed under the brand name Keytruda, works by turning off the immune system’s brakes, allowing its T-cells to recognize and attack cancer cells. It originally received accelerated approval by the FDA in 2015 as a treatment for NSCLC.

Until today’s approval, however, the drug was only given to patients after prior chemotherapy who expressed a biomarker known as PD-L1 on at least half of their cancer cells. Now, patients with PD-L1 expression on at least half of their cancer cells can receive pembrolizumab prior to standard chemotherapy.

The idea to specifically study this group of patients was based on groundbreaking research Garon published last year, which found that among patients who received pembrolizumab, those with PD-L1 expression on at least 50% of their cancer cells showed the longest survival and disease control. Garon’s work laid the foundation for additional research that led the way for today’s approval.

Issued concurrently by the FDA today is a new label update for pembrolizumab, which can now be prescribed to patients who express PD-L1 on as few as 1% of their cancer cells if they have received prior chemotherapy. This recommendation is based on a separate study, in which Garon was the senior author, showing longer survival than chemotherapy among patients with any positive staining for PD-L1.

Researchers are currently testing pembrolizumab to determine if it has the same result in other cancers, as well as trying to combine pembrolizumab with other therapies.

Lung cancer is the deadliest cancer worldwide and The American Lung Association estimates more than 158,000 people in the US will die from the disease this year alone. NSCLC accounts for approximately 85% of all lung cancers.

Tags:

Category: Features, Pharmaceuticals

Comments are closed.

Subscribe to HCA for exclusive updates

Top Viewed News

12 simple steps to a healthy lifestyle

12 simple steps to a healthy lifestyle

Now that the world has returned to normalcy following the pandemic, everyone is back to their daily routines and encounters with stress... Read More

AZBIL: Envisioning the Future of Hospitals

AZBIL: Envisioning the Future of Hospitals

As we strive to be the hospital of choice, why not refine our commitment to excellence beyond the pivotal mission of saving lives?... Read More

Study Unlocks Key Findings on Asian Carriers of Breast Cancer

Study Unlocks Key Findings on Asian Carriers of Breast Cancer

Malaysian researchers at Cancer Research Malaysia (CRMY) and the University of Nottingham Malaysia (UNM) have published... Read More

 Unmasking the Risks of Mercury-Laden Cosmetics

Unmasking the Risks of Mercury-Laden Cosmetics

As the saying goes, beauty is in the eye of the beholder and thus subjective; but in some countries, the ideal of beauty begins... Read More

5 key hospital etiquettes to be mindful of when visiting a sick patient

5 key hospital etiquettes to be mindful of when visiting a sick patient

In moments of illness, the presence of loved ones can comfort and support. However, it’s important for visitors... Read More

Free counters!

2025 Exhibitions



2025 Events


8-11 May
Vietnam Medi-Pharm
MITEC, KL
www.vietnammedipharm.vn


21-22 May
HealthTechX Asia
Sands Expo & Convention Centre, Singapore
www.healthtechx-asia.com


5-7 June
Medical Taiwan
Taipei Nangang Exhibition Center, Taipei, Taiwan
www.medicaltaiwan.com.tw


9-11 June
APHM International Healthcare Conference & Exhibition
KL Convention Centere, Kuala Lumpur, Malaysia
www.aphmconferences.com


12-14 June
International Health Industry Expo
China
www.ihe-china.com


24-26 June
CPhI China
SNIEC, Shanghai, China
www.cphi.com


25-26 June
Health Facilities Asia
Singapore
www.www.iqpc.com


25-27 June
Japan Health
INTEX Osaka, Japan
www.japanhealthonline.com


26-27 June
OSH India South
Chennai Trade Center, Bangalore
www.oshindia.com


9-11 July
Medical Device Development (MEDIX) – Osaka
Makuhari Messe, Japan
www.manufacturing-world.jp


14-16 July
Lab Asia
Kuala Lumpur Convention Centre (KLCC), Malaysia
www.lab-asia.com


16-18 July
Medlab Asia | Asia Health
Malaysia International Trade & Exhibition Centre, Kuala Lumpur
www.medlabasia.com


13-15 August
Philippines Medical
SMX Convention Center Manila Philippines
www.philmedical.com


21-23 August
REHACARE China
Suzhou, China
www.rehacare-c.com


21-23 August
Medical Fair China
Suzhou, China
www.medicalfair.cn


3-5 September
Bio Asia Pacific
BITEC, Bangkok
www.bioasiapacific.com


9-12 September
China Dental Show
National Exhibition and Convention Center (Shanghai)
www.chinadentalshow.com


10-11 September
Hospital Management Asia
Shangri-La Kuala Lumpur, Malaysia
www.hospitalmanagementasia.com


10-12 September
Medical Fair Thailand
BITEC, Bangkok
www.medicalfair-thailand.com


10-12 September
Malaysia Pharma and Healthcare Expo
Kuala Lumpur, Malaysia
www.mphcexpo.com


11-13 September
Bio Asia Pacific
BITEC, Bangkok
www.bioasiapacific.com


24-26 September
Medtec China
Shanghai, China
www.en.medtecchina.com


9-11 October
Medical Japan Tokyo
Makuhari Messe, Japan
www.medical-jpn.jp


17-19 October
Health Asia
BITEC, Bangkok
www.health-asia.com


17-19 October
Health Asia
BITEC, Bangkok
www.health-asia.com


7-8 November
Eldercare Exhibition and Conference Asia (ELDEX Asia)
Suntex Singapore Exhibition and Convention Centre
www.eldexasia.com


10-12 November
Saudi International Pharma Expo
Riyadh International Convention and Exhibition Center
www.saudipharmaexpo.com


10-12 November
Saudi International MedLab Expo
Riyadh International Convention and Exhibition Center
www.saudimedlabexpo.com


27-29 November
International Wellness Expo (IWE 2025)
METIC, Malaysia
www.internationalwellnessexpo.com


2026 Events


9-12 Febuary
Arab Health
Dubai World Trade Centre
www.arabhealthonline.com


15-17 April
Lab Indonesia
Jakarta Convention Center, Jakarta, Indonesia
www.lab-indo.com


9-11 September
Medical Fair Asia
Marina Bay Sands, Singapore
www.medicalfair-asia.com


9-11 September
Medical Manufacturing Asia
Marina Bay Sands, Singapore
www.medmanufacturing-asia.com