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FDA grants fast review for Bayer and MSD’s heart failure drug vericiguat

Photo by FDA

The FDA has granted a fast Priority Review for Bayer and MSD’s heart failure drug vericiguat.

This was based on data from the Phase 3 VICTORIA study, which met its composite primary endpoint as the drug reduced the risk of heart failure hospitalisation or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction when compared with a placebo control group.

European green light for Lynparza in germline BRCA-mutated metastatic pancreatic cancer

The European Commission has awarded approval to AstraZeneca and MSD’s Lynparza (olaparib) for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, with the drug becoming the only PARP inhibitor approved in Europe to treat the disease.

The ruling, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), specifically relates to gBRCAm patients with metastatic adenocarcinoma of the pancreas who have not seen disease progression following a minimum of 16 weeks of platinum treatment within a first line ch

Lynparza secures CHMP recommendation in first-line BRCA-mutated metastatic pancreatic cancer

Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has just secured recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) as a first-line maintenance treatment for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

The advice relates specifically to patients who have not seen their disease progress after receiving a minimum of 16 weeks of first-line platinum chemotherapy.

Lynparza combo authorised in US for first-line maintenance of HRD-positive advanced ovarian cancer

Lynparza (olaparib), developed by AstraZeneca and MSD, has secured FDA approval when paired with bevacizumab as a first-line maintenance treatment for homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

The indication covers adult patients who have completely or partially responded to first-line platinum-based chemotherapy and whose HRD-positive status is defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability.

MSD's Keytruda hits Phase 3 main goal in first-line colorectal cancer sub-population

MSD has lifted the veil on new Phase 3 for its blockbuster immunotherapy Keytruda, showing that the anti-PD-1 therapy met one of its main goals in the first-line treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.

Data gathered during an interim analysis conducted by an independent Data Monitoring Committee (DMC) showed that the drug generated a “statistically significant and clinically meaningful improvement” in progression-free survival compared to an investigator’s choice of chemotherapy, meeting

Keytruda rejected for NHS use for bladder cancer, will be removed from the Cancer Drugs Fund

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has been knocked back by NICE for use on the NHS as a treatment for locally advanced or metastatic urothelial carcinoma in patients who have previously undergone platinum-containing chemotherapy.

Data harvested during the drug’s availability via the Cancer Drugs Fund and submitted in support of the application could not adequately address the institute’s concerns over its long-term benefit.  

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

Lynparza tablets approved for NHS use in platinum-sensitive, BRCA-mutated ovarian, fallopian tube or peritoneal cancer

It has been announced that tablet form of Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has secured recommendation from NICE  for the treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in adult patients with a BRCA1 or BRCA2 mutation.

Data supplied in support of the case for the drug’s recommendation demonstrated that Lynparza presented a progression-free survival benefit of 19.1 months, compared to 5.5 months for placebo.

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.

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