GENE ONLINE|News &
Opinion
Blog

.

Зеркало официального сайта всегда доступно для входа на Мостбет, даже при ограничениях. Скачать Mostbet – это шаг к удобству и азартным развлечениям.

Если вы ищете место для увлекательных ставок, обратите внимание на Joycasino, где лучшие предложения для игроков ждут вас.
2021-02-24| Trials & Approvals

Libtayo’s Second Approval in One Month Sets Up Lung Cancer Duel with Merck’s Keytruda

by Tulip Chakraborty
Share To

On February 22nd, Regeneron Pharmaceuticals, Inc. and Sanofi announced that Libtayo, their PD-1 inhibitor, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) having high PD-L1 expression in tumors, as deemed appropriate by an FDA-approved test. With NSCLC forming approximately 84% of all lung cancers and an estimated 2.2 million cases reported globally last year, this news is sure to renew hopes among patients.

This is Libtayo’s third approval and was based on the data from the clinical study, EMPOWER-Lung 1. Previously, Libtayo grabbed its first FDA approval in 2018 for advanced cutaneous squamous cell carcinoma, and just two weeks ago, it further added basal cell carcinoma (BCC) to its name, making it the first immunotherapy approved for BCC. This helped them secure approximately $348 million in sales last year alone with an 80% year-over-year growth.

“The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, M.D., Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial.

Dr. Rizvi further added, “Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice”.

 

EMPOWER-Lung 1

Libtayo is a humanized monoclonal antibody that targets the human PD-1 protein. Inhibition of the PD-1 pathway blocks the cancer cells’ ability to suppress T-cell activation. EMPOWER-Lung 1 is a Phase 3 multicenter clinical trial aimed at demonstrating the safety and efficacy of Libtayo as monotherapy in lung cancer patients with >50% PD-L1 expression in tumor cells. A total of 710 patients with NSCLC were enrolled for this study. Libtayo reduced the risk of death by 32% compared to chemotherapy. The major adverse reactions observed were rashes, cough, and pneumonia.

 

Positioning in the Market

Libtayo enters the lung cancer market, which is dominated by Merck’s blockbuster drug Keytruda. Having been approved for not only NSCLC, but melanoma, head, and neck squamous cell cancer, Hodgkin lymphoma, large B-cell lymphoma, urothelial carcinoma, among many others, Keytruda has managed to rake in $14.4 billion, a 30% worldwide growth in 2020. It is going to be an uphill task for Libtayo to capture market-share from Merck.

Market analysts are debating whether Libtayo holds a slight edge over Keytruda by comparing the reductions in death risk and have concluded that data from EMPOWER-Lung 1 does not have the potential to shake off Keytruda’s market dominance.

However, both Regeneron and Sanofi think otherwise and have claimed that Libtayo has performed significantly well in varied patients at different stages of prognosis and have presented doctors with situations that they encounter in daily practice. Additionally, the companies plan to evaluate the use of Libtayo with other chemotherapy agents and intend to present the data soon. If all this falls into place, Regeneron and Sanofi are looking to chip into Merck’s dominance over the NSCLC market and gain momentum in sales.

Related Article: FDA Okay of Regeneron’s PD-1 Inhibitor Marks Entry of First Immunotherapy for Advanced Basal Cell Carcinoma

References

  1. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-monotherapy-patients-first
  2. https://www.geneonline.com/fda-okay-of-regenerons-pd-1-inhibitor-marks-entry-of-first-immunotherapy-for-advanced-basal-cell-carcinoma/

 

©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
JPM 2025 Looks at the Cell and Gene Therapy Landscape – Autoimmune, Cancer, and Chronic Diseases are Front and Center
2025-01-21
Cecile Richards’s Battle with Glioblastoma
2025-01-21
Neuro, Pain, and Cancer Top the List at JPM 2025 Healthcare Conference
2025-01-17
LATEST
Sodium Channel Targeting: What the Latest FDA Non-Opioid Approval Reveals About the Next Big Thing in Pain Relief
2025-02-12
Novartis Reclaims Abelacimab in $925M Deal to Boost Cardiovascular Portfolio
2025-02-12
GLP-1 Weight Loss Drugs Might Cause Blindness
2025-02-11
South Korea’s Olix Strikes $660M Deal with Eli Lilly for Phase 1 MASH candidate
2025-02-11
22 USA States Sue Trump Administration for Slashing Critical Medical Research Funding
2025-02-11
The Fallout of the USAID Funding Freeze: Implications for Global Health and Biopharmaceutical Innovation
2025-02-11
Trump’s Trade War Shake-Up: How U.S. Tariffs Could Disrupt Global Pharma
2025-02-10
EVENT
2025-02-19
Healthcare Conference Taipei 2025
Taipei, Taiwan
2025-03-17
BIO-Europe Spring 2025
Milan, Italy
2025-04-21
World Vaccine Congress Washington 2025
Washington, U.S.A
2025-04-21
World Vaccine Congress 2025
Washington, U.S.A
2025-04-25
AACR Annual Meeting 2025
Chicago, U.S.A
Scroll to Top