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New Keytruda dosing schedule rejected in six cancers by the FDA

MSD’s blockbuster immunotherapy Keytruda has been stopped in its tracks by the FDA after the US regulator rejected its application for a new dosing regimen in six different cancers: melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

The therapy is already approved in those cancers when taken at 200mg dose every three weeks; the manufacturer was seeking to add the new dosing schedule of 400mg every six weeks on the grounds that it would provide patients with greater flexibility and mak

NICE gives initial ‘no’ to NHS England for kidney cancer drug

The National Institute for Health and Care Excellence (NICE) has not recommended Keytruda (pembrolizumab) and Inlyta (axitinib) for the treatment of advanced renal cell cancer.

Keytruda is an immunotherapy treatment that works by blocking a protein called PD-1 on the surface of certain immune cells called T cells, triggering the body’s immune system to kill cancer cells. It would be used in combination with Inlyta, which is already used to treat people with advanced kidney cancer whose cancer has continued to progress after initial treatment.

NICE does not recommend cancer drug combination to the NHS

NICE has published draft guidance that does not recommend a new drug combination to combat untreated advanced renal cell carcinoma in adults (RCC).

The evidence from treating kidney cancer patients with pembrolizumab (Keytruda) and axitinib (Inlyta) showed promise, but NICE were concerned about its long-term benefit. Its clinical and cost-effectiveness estimates were also above what NICE would normally consider as an acceptable use of NHS resources. 

Seattle Genetics and Astellas unveil positive results for Padcev-Keytruda treatment for bladder cancer

Seattle Genetics and Astellas reported positive results from their trials of Padcev plus Keytruda in treating bladder cancer.

The data from the Phase 2 trial shows that the treatment is meeting “outcome measures for safety and demonstrating encouraging clinical activity.” It was tested on two groups comprising 45 patients.

NICE shoots down Keytruda in head and neck cancer over data concerns

It has been revealed that NICE has chosen to reject MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) for routine use on the NHS as a treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), citing uncertainty over the data provided by the manufacturer.

Data submitted to the institute argued that Keytruda, either as a monotherapy or in combination with platinum chemotherapy and 5-FU, extended overall survival in those with PD-L1 positive HNSCC compared to Eli Lilly’s Erbitux (cetuximab) plus platinum chemotherapy and 5-FU.

MSD's Keytruda chalks up bladder cancer approval in the US

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

Bittersweet Phase 3 Keytruda data hits one of two goals in extensive stage small cell lung cancer

MSD has lifted the curtain on new Phase 3 data on the efficacy of its blockbuster immunotherapy Keytruda, in combination with etoposide plus cisplatin or carboplatin chemotherapy, in the treatment of extensive stage small cell lung cancer (ES-SCLC) in the first-line setting, showing that the combo met one of its primary endpoints, but not both.

FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer

An FDA advisory committee voted 9 to 4 in favour of recommending Merk and Co’s Keytruda (pembrolizumab) for treatment in patients with high-risk, non-muscle-invasive bladder cancer (NMIBC).

The FDA is expected to reach a decision, based on a priority review, in January 2020.

Prostate Cancer ‘super responders’ could live for two more years on Keytruda

Men with advanced prostate cancer, who have exhausted all treatment options, could use the immunotherapy Keytruda (pembrolizumab) to live for another two years or more.

A major clinical trial showed that a small proportion of men were ‘super responders’ and were alive and well even after the trial had ended, despite having had a very poor prognosis before treatment.

Europe approves Keytruda for first-line head and neck squamous cell carcinoma, as a monotherapy or combo

MSD’s top-selling immunotherapy Keytruda (pembrolizumab) has secured another approval from the European Commission, this time in the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients whose tumours express PD-L1.

Phase 3 data supporting the application demonstrated that Keytruda significantly improved overall survival compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), either as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy.

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