Keytruda's Most Recent FDA Approvals
Keytruda (pembrolizumab), Merck's PD-1 inhibitor for cancers like melanoma and lung cancer, received FDA approval on December 27, 2023, for first-line treatment of unresectable advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults and children aged 12+ weighing at least 88 pounds, combined with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy.[1] It also gained accelerated approval on October 17, 2023, for high-risk (intermediate-, high-, or very high-risk) resected non-small cell lung cancer (NSCLC) as adjuvant therapy after surgery and platinum-based chemotherapy.[1]
Approvals in 2024 So Far
No new FDA approvals for Keytruda occurred in 2024 through mid-year. The label update for gastric/GEJ cancer reflects 2023 data, with ongoing reviews for expanded uses like earlier-stage NSCLC combinations.[1][2]
Key Pending Approvals and Label Expansions
Merck submitted sBLA for Keytruda plus chemotherapy in earlier-stage gastric cancer (November 2023, PDUFA June 2024).[2] Another sBLA targets adjuvant therapy post-resection and chemotherapy for high-risk, node-positive gastric/GEJ cancer (accepted February 2024).[2] European Commission approved subcutaneous Keytruda formulation on April 25, 2024, but this is not FDA.[3]
Why Recent Approvals Matter for Patients
These build on Keytruda's 40+ indications since 2014, targeting immunotherapy in solid tumors. Expanded adjuvant uses aim to prevent recurrence earlier, potentially extending survival in NSCLC and gastric cancers where surgery alone fails 40-50% of cases.[1]
Patent Status and Biosimilar Timeline
Keytruda's core composition-of-matter patent (US 8,008,449) expires January 2028, with pediatric exclusivity to July 2028; method-of-use patents extend protection into the 2030s. Challenges from Amgen, Samsung Bioepis, and others are ongoing, but no biosimilars launch before 2028.[4]
[1]: FDA.gov - Keytruda Label (updated 2024) - https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-first-line-treatment-her2-positive-gastric-or-gastroesophageal-junction
[2]: Merck.com - Press Releases (2023-2024) - https://www.merck.com/news/merck-receives-priority-review-from-fda-for-submission-of-supplemental-biologics-license-application-for-keytruda-pembrolizumab-plus-chemotherapy-as-treatment-for-patients-with-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-junction/
[3]: EMA.europa.eu - Keytruda Subcutaneous Approval - https://www.ema.europa.eu/en/medicines/human/EPAR/keytruda
[4]: DrugPatentWatch.com - Keytruda Patents - https://www.drugpatentwatch.com/p/tradename/KEYTRUDA