AstraZeneca’s Lynparza (olaparib) is nearing the finishing line in Europe as a maintenance treatment for patients with ovarian cancer who have a BRCA mutation, after receiving a thumbs up from the Committee for Medicinal Products for Human Use.
Specifically, the CHMP has endorsed the drug’s use as monotherapy for platinum-sensitive, relapsed, BRCA-mutated, high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in response (complete or partial) to platinum-based chemotherapy.
If approved, Lynparza will be the first in a new class of drugs known as PARP inhibitors to become available in the region. These work by exploiting a weakness in cells with mutations to the BRCA genes, and have shown potential in clinical trials against breast, ovarian and prostate cancer in patients with BRCA1 or BRCA2 mutations. A key advantage seems to be their targeted cancer cell killing capabilities which cause less side effects than traditional chemotherapy approaches.
An approval by the European Commission would mark “an important moment in the development of targeted treatments for cancer”, said Professor Alan Ashworth, Professor of Molecular Biology at The Institute of Cancer, also noting that it would be “a significant step in expanding the treatment options available for patients with tumours caused by inherited BRCA mutation”.
Meanwhile, five other drugs were put forward by the CHMP for approval, including two for orphan conditions.
First therapy for light intolerance disorder?
Marking the first potential therapy for patients with the rare genetic disease erythropoietic protoporphyria (EPP), which causes intolerance to light, Clinuvel’s Scenesse (afamelanotide) was backed under exceptional circumstances, in this case because there is a lack of robust efficacy data due to the difficulties in conducting placebo-controlled trials in this indication.
The CHMP has recommended the drug’s approval on the condition that Clinuvel puts in place a “robust risk management plan” that ensures close surveillance of its safety and efficacy. As part of this, the firm will establish a registry of patients to collect safety and efficacy data.
During the evaluation process for Scenesse, patients were invited to discuss their experiences of the condition, marking the first time that patients have been involved in CHMP discussion on the benefits and risks of a medicine.
Elsewhere, recommendations also came in for: Pfizer’s Duavive (conjugated oestrogens/bazedoxifene) as a new treatment option for oestrogen deficiency; Baxter’s Rixubis (nonacog gamma) for the treatment and prophylaxis of bleeding in patients with haemophilia B; Duloxetine Lilly (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder; and Paliperidone Janssen (paliperidone) for the treatment of schizophrenia.
Safety reviews
The CHMP also concluded its review of the benefits and risks of Ariad Pharma’s leukaemia drug Iclusig (ponatinib), recommending strengthened warnings in the product information to minimise the risk of blood clots and blockages in the arteries.
After reviewing the safety and efficacy of medicines containing the antibiotics colistin or colistimethate sodium (known as polymyxins), the Committee recommended changes to the product information of products for injection or inhalation to ensure their safe and effective use in the treatment of serious infections that are resistant to standard antibiotics.
