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FDA approves Keytruda + Lenvima to treat advanced endometrial cancer – Merck Inc.+ Eisai

Written by | 15 Aug 2021

The FDA has approved pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR),… read more.

FDA accepts sBLA for Keytruda in high-risk stage II melanoma – Merck Inc

Written by | 13 Aug 2021

Merck Inc announced that the Phase III KEYNOTE-716 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of recurrence-free survival (RFS) for the adjuvant treatment of… read more.

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Written by | 9 Aug 2021

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy… read more.

FDA approves expanded label for Keytruda for locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation – Merck Inc.

Written by | 12 Jul 2021

Merck has announced that the FDA has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous… read more.

Merck Inc provides update on Keytruda indication in third-line gastric cancer in the US

Written by | 11 Jul 2021

Merck announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric… read more.

FDA grants priority review to Keytruda + Lenvima for advanced endometrial carcinoma – Merck Inc + Eisai

Written by | 20 May 2021

Merck Inc and Eisai announced that the FDA has accepted and granted priority review for an application seeking new approval for the combination of Keytruda (pembrolizumab) plus Lenvima… read more.

FDA approves Keytruda + Herceptin in HER2-positive gastric or gastroesophageal junction adenocarcinoma – Merck Inc.

Written by | 16 May 2021

Merck Inc announced that the FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients… read more.

Keytruda monotherapy is EU approved for adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma – Merck Inc

Written by | 31 Mar 2021

Merck announced that the European Commission (EC) has approved an expanded label for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged… read more.

Merck announced the withdrawal of the U.S. indication for Keytruda for the treatment of patients with metastatic small cell lung cancer

Written by | 5 Mar 2021

Merck announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression… read more.

Merck Inc. receives positive CHMP opinion for expanded approval of Keytruda in certain patients with relapsed or refractory classical Hodgkin lymphoma

Written by | 17 Feb 2021

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an expanded… read more.

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