Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally adv...
indications (see indications below) and is approved for advanced disease in more than 95 countries. Among Merck’s research efforts are trials focused on evaluating KEYTRUDA in earlier stages of lung cancer as well as...
Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received Keytruda as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a media...
In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer wh...
PD-L1 (combined positive score [CPS] ≥10, as determined by an FDA-approved test) was changed to regular approval. 帕博利珠单抗适应症扩展至早期三阴性乳腺癌(TNBC) 帕博利珠单抗联合化疗用于高风险、早期、TNBC的新辅助治疗,且后续进行帕博利珠单抗单药辅助治疗获批。该批准是基于随机、多中心、双盲、安慰...
Keytruda FDA Approval HistoryLast updated by Judith Stewart, BPharm on Oct 2, 2024. FDA Approved: Yes (First approved September 4, 2014) Brand name: Keytruda Generic name: pembrolizumab Dosage form: for Injection Company: Merck Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, ...
“We are encouraged by the meaningful discussion and positive votes to maintain the … liver cancer indications reviewed for Keytruda.” During the meeting, the committee members expressed concern in upholding the accelerated approval because of a low response rate a...
The FDA has issued a complete response letter to Merck and Eisai stating that it will not approve the applications that are seeking the accelerated approval of pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for the frontline treatment of patients with unresectable hepatocellular carcin...
FDA approvals of PD-1/PD-L1 mAbs. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic conditions. Shown are the approvals for each cancer indication, for Keytruda (pembrolizumab), Opdivo (nivolumab),...
With concerns over its blockbuster anti-PD-1 therapy Keytruda’s potential loss of exclusivity post-2028, the approval of new drugs like Welireg for additional indications should help Merck lower its dependence on Keytruda in future quarters. ...