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
Ideal Cures will operate as a fully independent entity within Colorcon. Their business complements Colorcon’s position in the Indian pharmaceutical market with a strong presence in the domestic generic sector comprised of long-standing customer relationships sustained by innovative and customized solutions.
Across four new breast cancer treatments approved by the FDA last year, 2% to 9% of patients in clinical trials for the drugs were Black Americans and 0% to 9% were Hispanic, according to a new report from Breastcancer.org.
The southern section of Jernbanebyen in central Copenhagen has a new owner. The Baneby Consortium, comprising NREP, Novo Holdings and Industriens Pension, has bought the land from Freja Ejendomme. The ambition is to create a green, partly car-free environment that will also be one of the healthiest in the world.
