GlaxoSmithKline’s Zejula and AstraZeneca’s Lynparza have both moved towards EU approval in new indications after receiving positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Zejula (niraparib) won a positive opinion recommending it for approval as a first-line monotherapy maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
The application is based on data from GSK’s phase III PRIMA study, which demonstrated a clinically meaningful progression-free survival benefit of Zejula treatment in the first-line setting.
If the EMA decides to fully approve Zejula in this indication, it could become the first monotherapy PARP inhibitor to be backed as a first-line maintenance treatment following platinum response regardless of BRCA mutation status, according to GSK.
Lynparza, on the other hand, has been recommended for approval in the EU for patients with metastatic castration-resistant prostate cancer (mCRPC), with BRCA 1/2 mutations. The CHMP also backed the PARP inhibitor for use as a first-line maintenance treatment, in combination with bevacizumab, for HRD-positive advanced ovarian cancer.
The mCRPC recommendation is based on results from a subgroup analysis of patients with BRCA 1/2 mutations in the PROfound phase III trial.
In the phase III PAOLA trial, Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% in HRD-positive advanced ovarian cancer patients.
“Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting,” said José Baselga, executive vice president, Oncology R&D at AZ.
By: Lucy Parsons
Source: Pharma Times
A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.
Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.
Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”
