Keytruda, FDA and Head

Can Keytruda finally break into early head and neck cancer?
Keytruda has been approved since 2016 as a second-line option after chemotherapy for patients with more advanced HNSCC that has spread to other parts of the body and moved into the first-line setting in 2019 as monotherapy or in combination with chemo for patients whose tumours express elevated levels of the PD-L1 biomarker.
Merck Gets Speedy FDA Review of Keytruda in Certain Head, Neck Cancers
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its blockbuster cancer drug Keytruda in certain patients with head and neck cancer.
FDA Grants Priority Review to Merck’s Keytruda for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major pathological response in patients with resectable locally advanced head and neck squamous cell carcinoma.
Merck expects cancer therapy Keytruda to be part of government price setting in 2026
(Reuters) -Drugmaker Merck said on Tuesday it expects its top selling cancer therapy Keytruda to be selected in 2026 for government price setting, which would become effective on January 1, 2028. The company said in a regulatory filing it expects U.
Merck expects Keytruda to face HHS price setting in 2026
Merck (NYSE:MRK) said it expects its top-selling drug, Keytruda, to be selected by the U.S. government for price setting negotiations next year under the Inflation Reduction Act. In a filing with the SEC,
Cure Today2d
FDA Accepts Priority Review for Pre- and Postsurgical Keytruda in HNSCC
The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...
Cancer Therapy Advisor1d
Pembrolizumab Granted Priority Review for Resectable, Locally Advanced HNSCC
The US Food and Drug Administration has accepted for priority review the supplemental biologics license application for pembrolizumab (Keytruda) to treat patients with resectable, locally advanced ...
Purple Biotech Advances NT219 into Phase 2 Head and Neck Cancer Trial
NT219, a novel agent designed to overcome tumor resistance to drug therapy, will be evaluated in combination with the ...
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Pharma Stock Roundup: LLY Ups U.S. Manufacturing Investments & More
Eli Lilly LLY announced that it is increasing its manufacturing capacity in the United States by building four new plants.
Nasdaq10d
Purple Biotech Advances Phase 2 Study of NT219 in Combination with Keytruda and Erbitux for Head and Neck Cancer Patients
will be evaluated in combination with the standard-of-care head and neck cancer drugs pembrolizumab (Keytruda) or cetuximab (Erbitux) The study is conducted in collaboration with the ...
Targeted Oncology2d
FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC
The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...
Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer
Receiving Fast Track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R/M HNSCC. This ...