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2 clusters · 24 sources · 23 days · First seen · Last updated
Keytruda therapeutic expansions and approvals
Overview
The immunotherapy drug Keytruda has seen recent developments regarding new formulations and expanded clinical applications.
In South Korea, MSD Korea announced the October launch of a subcutaneous (SC) formulation of Keytruda. Utilizing Alteogen’s ‘berahyaluronidase alfa’, this version aims to significantly reduce administration time from approximately 30 minutes for intravenous doses to between 1 and 2 minutes. Clinical studies indicated that the SC formulation is non-inferior in drug exposure to the intravenous version and was preferred by 65% of patients in a crossover study due to increased comfort and shorter hospital stays.
In the European Union, the European Commission has approved a combination of Keytruda and Padcev for the perioperative treatment of adults with resectable muscle-invasive bladder cancer (MIBC). This regimen can be used as neoadjuvant therapy before radical cystectomy or as adjuvant treatment following surgery. The authorization covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
The approval follows the Phase III KEYNOTE-B15/EV-304 study, which showed the combination reduced the risk of disease recurrence, progression, or death by 47% compared to standard chemotherapy and surgery. This regulatory decision provides a treatment option for patients regardless of their eligibility for cisplatin-based chemotherapy, a group that includes approximately 50% of patients.
Entities
Keytruda · MSD · European Medicines Agency · Alteogen · Astellas
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 5 SOURCES] The European Commission approved pembrolizumab and enfortumab vedotin for resectable muscle-invasive bladder cancer. www.forchecaudine.com · mantovauno.it · www.pharmaceutical-business-review.com · www.vetrinatv.it · cn24tv.it
- [● 3 SOURCES] The treatment is intended for use as both neoadjuvant and adjuvant therapy. www.forchecaudine.com · www.pharmaceutical-business-review.com · mantovauno.it
- [● 2 SOURCES] The treatment is applicable to patients regardless of cisplatin eligibility. mantovauno.it · www.pharmaceutical-business-review.com
- [○ 1 SOURCE] The combination therapy lowered the risk of disease recurrence, progression, or death by 47% compared to cisplatin and gemcitabine chemotherapy. www.pharmaceutical-business-review.com
- [○ 1 SOURCE] The approval covers all 27 EU member states, Iceland, Liechtenstein, and Norway. www.pharmaceutical-business-review.com
- [○ 1 SOURCE] ctDNA clearance before surgery was higher with enfortumab vedotin plus pembrolizumab than with cisplatin and gemcitabine. www.cancernetwork.com
- [○ 1 SOURCE] The 24-month event-free survival (EFS) rate was 71.2% with enfortumab vedotin plus pembrolizumab versus 54.2% with chemotherapy among patients with detectable ctDNA at baseline. www.cancernetwork.com
Timeline
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[HEALTH] 24 sourcesEuropean Commission approves bladder cancer treatment
The European Commission approved pembrolizumab and enfortumab vedotin for perioperative treatment of resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility.
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[HEALTH] 4 sourcesMSD Korea to launch subcutaneous Keytruda in October
MSD Korea is launching the subcutaneous formulation of Keytruda in October, reducing annual administration time by 96.7% and improving patient convenience across 18 cancer types.
Sources
cagliarilivemagazine.it · cancernetwork.com · cn24tv.it · codirp.it · corcianonline.it · egnews.it · entilocali-online.it · forchecaudine.it · ilfattonisseno.it · innlifes.com · lamilano.it · lsdmagazine.com · mantovauno.it · notizie.it · notiziedi.it · periodicodaily.com · pharmaceutical-business-review.com · quotidianodibari.it · sardegnareporter.it · senzalinea.it · socialfarma.it · technoblitz.it · trapanisi.it · vetrinatv.it
This summary has been updated 2 times: see revision history