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Medicare will cover CAR-T therapies in United States

Medicare will cover the cost of Novartis’ and Gilead’s CAR-T therapies Kymriah and Yescarta, the US Centers for Medicare and Medicaid services (CMS) said.

Medicare, the federal government’s health plan for over-65s has said it will cover the FDA approved CAR-T therapies Kymriah and Yescarta when provided in healthcare facilities that have programmes in place to track patient outcomes, known as REMS.

Keytruda/chemo combo recommended for first-line lung cancer via Cancer Drugs Fund

MSD’s Keytruda (pembrolizumab) has secured recommendation from NICE for inclusion on the Cancer Drugs Fund (CDF) in combination with chemotherapy in the first-line treatment of untreated metastatic squamous non-small cell lung cancer (NSCLC), it has emerged.

The final appraisal determination marks the first for a immunotherapy/chemotherapy combo in this indication regardless of PD-L1 expression.

MSD's Keytruda combo hits primary endpoint at Phase 3 in triple-negative breast cancer

MSD’s blockbuster anti-PD-L1 immunotherapy Keytruda (pembrolizumab) has impressed in newly released Phase 3 data; the company announced that, when combined with chemotherapy, the drug met one of its primary endpoints in the treatment of triple-negative breast cancer (TNBC).

Findings derived from a study of 1,174 TNBC patients and analysed by the independent Data Monitoring Committee demonstrated that Keytruda generated a “statistically significant improvement” in rates of pathological complete response (pCR) compared to chemo alone, regardless of PD-L1 status, as determined by a la

MSD's Keytruda snatches up first approval in small cell lung cancer

MSD has revealed that its anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been awarded marketing authorisation from the FDA as a monotherapy in the treatment of metastatic small cell lung cancer (SCLC) in adults whose disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The approval was given under the FDA’s accelerated review pathway, and was based on data from 83 participants across two trials, 64% had received two prior lines of therapy and 36% had received three or more; 60% had received prior thoracic radiation therapy

Longest follow up trial of Merck's Keytruda sets new standard for five year survival in lung cancer

Nearly a quarter of previously untreated lung cancer patients who took Keytruda (Pembrolizumab) were alive after five years, according to the results of the longest follow-up trial for Merck’s cancer immunotherapy.

In total, 23.2% of treatment naïve patients with advanced non-small cell lung cancer (NSCLC) were alive after five years.

The data from the phase 3 KEYNOTE trial of 616 patients showed that 23.2% of previously untreated and 15.5% of previously treated patients lived for more than five years after receiving MSD’s immunotherapy.

Keytruda fails to improve overall survival in advanced triple-negative breast cancer

MSD has made it known that its cancer immunotherapy Keytruda (pembrolizumab) failed to meet its primary endpoint in a Phase 3 study evaluating its efficacy as a monotherapy for the second- or third-line treatment of metastatic triple-negative breast cancer (TNBC).

The company revealed that the blockbuster anti-PD-1 drug failed to show superiority in improving overall survival compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). Because this primary endpoint was never met, all other endpoints were not formally tested.

MSD's Keytruda recommended on NHS in Scotland for Stage 3 melanoma

MSD has revealed that Keytruda (pembrolizumab) will be made available to NHS Scotland patients after the Scottish Medicines Consortium (SMC) decided to recommend the drug’s use as a monotherapy in the treatment of Stage 3 melanoma with lymph node involvement in adult patients who have undergone complete resection.

Thanks to the decision, access to the drug in this indication is now harmonised across the Great British mainland, following a recommendation from NICE in December 2018 to make the immunotherapy available on the NHS in England and Wales.

Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer

MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination with Pfizer’s Inlyta (axitinib) in advanced renal cell carcinoma.

The FDA made the decision based on Phase 3 data which showed that the combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Pfizer’s Sutent (sunitinib).

FDA expands Keytruda label to include stage 3 and 4 non-small cell lung cancer

MSD has revealed that its anti-PD-1 therapy Keytruda (pembrolizumab) has received expanded indication from the FDA to include the first-line treatment of stage 3 or metastatic non-small cell lung cancer (NSCLC).

Specifically, the indication relates to stage 3 patients who are not candidates for surgical resection or definitive chemoradiation, and those whose tumours express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

China approves Keytruda for non-small cell lung cancer

US firm MSD has won approval for Keytruda in China. The cancer immunotherapy has thus become the first PD-1 inhibitor approved for multiple tumour types in China.

The approval makes Keytruda (pembrolizumab) a first line treatment option alongside chemotherapy for patients in China with metastatic non-squamous non-small cell lung cancer (NSCLC). The indication brought in more than $7 billion in sales in 2018.

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