The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the uses of AstraZeneca’s Lynparza and Sanofi’s Dupixent.
Lynparza was recommended as monotherapy for the treatment of adults with germline BRCA1 and/or BRCA2-mutated (BRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The decision is based on the Phase III OlympiAD trial, which tested the drug against the physician’s choice of chemotherapy.
Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer at Merck Research Laboratories - who co-develop Lynparza - said: “The positive opinion from CHMP for Lynparza in this patient population is an important milestone.
"This decision brings us one step closer to offering a new treatment option to patients with locally advanced or metastatic breast cancer and further underscores the critical need to identify patients’ BRCA status, in addition to hormone receptor and HER2 expression status, as part of the management of this disease.”
Lynparza is currently already approved in over 60 countries, including those in the EU for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status.
The CHMP’s positive opinion for Dupixent means it is likely to be approved in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation.
This strain of asthma is characterised by raised blood eosinophils or raised FeNO, and tends to be inadequately controlled with high dose inhaled corticosteroid in combination with another medicinal product for maintenance treatment.
“Patients with severe asthma can face a daily struggle, not knowing whether they will face an unpredictable exacerbation, which can be frightening, and if uncontrolled, may lead to death,” said Dr Jasmin Hussein, head of Dermatology and Respiratory, Sanofi Genzyme.
The CHMP positive opinion for dupilumab" marks an important milestone for patients with severe asthma, moving us one step closer to bringing another treatment option for this potentially life-threatening disease to those in greatest need.”
It is currently already approved in the EU for use in adults with moderate-to-severe atopic dermatitis, and are candidates for systemic therapy.