Novartis’ lung cancer treatment Zykadia (ceritinib), Otsuka’s kidney disease drug Jinarc (tolvaptan) and Amgen’s neutropenia therapy Ristempa (pegfilgrastim) have taken a giant step closer to entering the European market after regulatory advisors endorsed their approval.
The Committee for Medicinal Products for Human Use (CHMP) has recommended conditional clearance for Zykadia (ceritinib) to treat adults with a certain type of non-small cell lung cancer, concluding that, while the full batch of safety and efficacy studies has not been completed, the drug does fulfil an unmet medical need.
The company is hoping to get Zykadia on the market to treat anaplastic lymphoma kinase (ALK) positive NSCLC, when the disease is at the advanced stage and patients have already been treated with Pfizer’s Xalkori, currently the only approved medicine on the market for this patient group. Not all patients respond to treatment with Xalkori, and disease progression typically occurs in any case, leaving patients in dire need of a new treatment option.
As per the terms of the proposed conditional approval, Novartis would have to provide the regulator with further results from ongoing studies and a comparative Phase III study within the next three years.
The CHMP is also recommending approval of Jinarc (tolvaptan) to slow the progression of cyst development and renal insufficiency in certain patients with autosomal dominant polycystic kidney disease (ADPKD).
Because of the potential for liver toxicity, a pharmacovigilance plan for Jinarc will be implemented on approval, and it is also proposed that treatment be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of this therapy.
Elsewhere, the CHMP has granted a positive opinion for Ristempa (pegfilgrastim) for the treatment of neutropenia. Specifically, the recommended indication is for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
New insulin formulation
Meanwhile, the CHMP also recommended the addition of a new formulation to the marketing authorisation of Sanofi’s Optisulin (insulin glargine) and a change of its invented name to Toujeo.
The new formulation of Toujeo is a higher-strength insulin (300 units/ml). Insulin glargine 100 units/ml was first approved in the EU as Lantus and Optisulin in June 2000.