PARIS, Feb 3 (APM) - France’s drugs regulator ANSM has granted early access (ATU de cohorte) for three cancer drugs - Eisai’s Lenvima (lenvatinib), Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck Sharp & Dohme’s Keytruda (pembrolizumab).

ANSM said the initial evaluation commission, which assesses the risk-benefit ratio of health products, unanimously issued an opinion in favour of use Lenvima 4 mg or 10 mg capsules in the treatment of patients with differentiated thyroid cancer refractory to radioactive iodine and in progression.

“Previous treatment, for this stage, should have involved Bayer’s Nexavar (sorafenib) except in case of contra-indication,” ANSM said in a brief summary of the meeting, held late last week.

Concerning Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck Sharp & Dohme’s Keytruda (pembrolizumab), the commission also unanimously agreed to widen the indications covered by the group ATU to patients with mutated BRAF who have failed to respond to BRAF inhibitor and who are naïve to ipilimumab, in the treatment of patients aged over 18 presenting a stage III/IV melanoma.

Until now, in patients with mutated BRAF, their ATUs applied in third line, following failure with a BRAF inhibitor and BMS’s Yervoy (ipilimumab).

The commission also unanimously issued opinions in favour of three temporary use recommendations (RTUs) for drugs already on the market.

The first two concern Amgen’s Nplate (romiplostim in a solution for injection), and GlaxoSmithKline’s Revolade (eltrombopag tablets) for use in the “treatment of chronic idiopathic auto-immune thrombocytopenic purpura refractory to other treatments (for instance, corticosteroids, immuglobulins) in children aged one year and over”.

For Nplate, the RTU applies “subject to the provision of a monitoring protocol including a suitable dilution procedure for administration to children with a low weight, or, and preferably, in a pharmaceutical form suitable for children with a low weight”. Concerning Revolade, this paediatric RTU is intended for children weighing over 35 kg.

The third RTU concerns Johnson & Johnson group-member Janssen’s psoriasis and psoriatic arthritis treatment Stelara (ustekinumab) for use in active moderate to severe Crohn’s disease in adults who have failed to respond satisfactorily to at least two anti-TNF alphas and to Takeda’s Entyvio (vedolizumab), or who either have tolerability problems with these drugs or in whom these treatments are contra-indicated.

On the other hand, the commission was divided on the prescription terms and conditions for the drug in this RTU. By eight votes to three, a dose of 90 mg was recommended administered by subcutaneous injection in week 0, in week 4 and then every eight weeks. Hypersensitivity and clinically important active infection are both contra-indications.

The initial prescription needs to be drawn up in hospital and is reserved for internal medicine or gastroenterology specialists. In case of absence of response at three months, the treatment should be stopped.

RTUs were brought in under a new law in 2011 in the wake of the Mediator scandal. It involves monitoring products used off label for three years with the aim of controlling the level of off-label prescribing.

eh/aki/hlc