What cancers has Keytruda received approval to treat?
Keytruda (pembrolizumab) holds FDA approval for non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high or mismatch repair-deficient solid tumors, gastric cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high solid tumors, cutaneous squamous cell carcinoma, triple-negative breast cancer, and esophageal cancer.
Which additional cancers are under active investigation for Keytruda?
More than 1,000 clinical trials are exploring pembrolizumab in other solid tumors and hematologic malignancies, including ovarian cancer, pancreatic cancer, colorectal cancer without microsatellite instability, prostate cancer, glioblastoma, and various sarcomas. Results from these studies will determine whether regulators expand the label.
How does Keytruda compare with Opdivo across approved indications?
Both drugs block PD-1, yet Keytruda carries broader single-agent approvals in lung, melanoma, and renal cancers, while Opdivo holds more combination approvals with ipilimumab. Head-to-head data remain limited; choice often rests on trial results, toxicity profiles, and reimbursement.
When do Keytruda patents expire?
Merck’s composition-of-matter patent for pembrolizumab expires in 2028 in the United States, with some method-of-use patents extending to 2032. Biosimilar or biobetter competition could appear as early as 2028 if regulatory and litigation pathways clear.
Why are companies challenging Keytruda patents?
Generic and biosimilar makers argue that certain use patents are obvious or insufficiently enabled. Ongoing inter partes review and district-court cases focus on dosing regimens and combination claims. Outcomes will influence launch timing and pricing.
Can biosimilars reach the market before patent expiry?
No biosimilar version of pembrolizumab has gained approval yet. Any abbreviated biologic license application filed now would face both patent litigation and data-exclusivity barriers, pushing likely entry to 2028 or later.
How much does Keytruda cost without insurance?
List price for one 200 mg dose every three weeks exceeds $10,000, translating to roughly $150,000–$200,000 annually. Actual out-of-pocket cost depends on insurance coverage, patient-assistance programs, and negotiated discounts.
What side effects are patients asking about most?
Common reports include fatigue, rash, diarrhea, and endocrine disorders such as hypothyroidism. Less frequent but serious immune-related toxicities involve colitis, pneumonitis, hepatitis, and nephritis. Monitoring schedules and early intervention reduce severe outcomes.
[1] DrugPatentWatch.com