Ten new medicines have taken a giant leap closer to European Union approval after having won the backing of the Committee for Medicinal Products for Human Use.
The Committee has put forward three new drugs for the treatment of cancer: Lilly's Lartruvo (olaratumab) for advanced soft tissue sarcoma; Pfizer's Ibrance for locally-advanced or metastatic breast cancer; and Takeda's Ninlaro for multiple myeloma.
Lartruvo is a monoclonal antibody recommended for conditional approval for use alongside the chemotherapy doxorubicin in patients with advanced soft tissue sarcoma (STS) for whom surgery or radiotherapy is not suitable, and who have not been previously treated with doxorubicin.
Forty to sixty percent of patients with STS will be in an advanced stage of the disease, and only half will live longer than five years under currently available treatment. This prognosis has not changed over the last forty years, highlighting the urgent need for new and more effective options.
The CHMP recommendation is based on data from a Phase II study in STS patients, who had not been previously treated with doxorubicin, which showed a median survival gain of 11.8 month patients taking the combination versus those on the chemotherapy alone.
Ibrance targets women with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.
The drug works by blocking the activity of proteins known as cyclin-dependent kinases (CDK) 4 and 6, which inhibits the division of cancer cells and helps to stop growth of the tumour. In one late-stage trial, patients who received Ibrance lived on average 24.8 months without their disease getting worse, compared to 14.5 months in those taking letrozole alone.
Ninlaro had actually been turned down by the Committee earlier this year, but adopted a positive opinion for conditional approval following a re-examination of the drug. However, further confirmatory data will need to be provided by the company as a condition for marketing authorisation.
The drug is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, and it is proposed that therapy must be initiated and monitored under the supervision of a physician experienced in the management of the disease.
Other recommendations were handed down for: Boehringer Ingelheim's Glyxambi (empagliflozin/linagliptin) for type 2 diabetes; and Amgen's Parsabiv (etelcalcetide) for secondary hyperparathyroidism.
Also, Sigma-tau Arzneimittel's hybrid application for Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid) picked up a positive opinion for cerebrotendinous xanthomatosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
Four generic medicines also won CHMP backing: Ivabradine JensenR (ivabradine) and Ivabradine Zentiva (ivabradine) to treat angina pectoris and heart failure, Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine/tenofovir disoproxil) to treat HIV infection and Granpidam (sildenafil) for the treatment of patients with pulmonary arterial hypertension.