CHMP recommends Avastin + chemotherapy for resistant Ovarian Cancer- Roche
Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the use of Avastin (bevacizumab) in combination with chemotherapy as a treatment for women with Ovarian Cancer that is resistant to platinum-containing chemotherapy. Ovarian Cancer has the highest mortality rate of all gynaecological cancers. Of the 230,000 women diagnosed worldwide each year many will have advanced disease that will return after initial treatment.
The new EU filing was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant Ovarian Cancer who received either chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) or Avastin added to chemotherapy. Results showed that at a median follow-up of 13 months for women who had received chemotherapy alone and 13.9 months for those who had received the combination, the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median PFS from 3.4 months to 6.7 months (HR=0.38, p<0.0001).>0.0001).>
Related news and insights
Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Olumiant (baricitinib) for the treatment of adults with severe alopecia areata (AA).
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg.
Mirati Therapeutics announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for MRTX 849 (adagrasib) for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.