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Tecentriq’s triple negative breast cancer use among key CHMP nods

Extensions for AZ drugs, new approval for La Jolla

ema

Roche’s Tecentriq has gained a recommendation for approval in triple-negative breast cancer from Europe’s CHMP, setting it on track for a significant new market opportunity.

The nod from the European Medicines Agency’s key committee was one of several new recommended extensions announced on Friday for drugs already on the market, with three new medicines also gaining a green light.

The Tecentriq recommendation is based on its use as a combination treatment with chemotherapy, for adult patients with metastatic triple-negative breast cancer whose tumours have PD-L1 expression of less than 1%, and who have not received prior chemotherapy treatment.

The recommendation is based on Tecentriq’s phase 3 IMpassion130 study, which showed that the drug combined with nab-paclitaxel significantly reduced the risk of disease deterioration or death, in patients who were positive for PD-L1 expression.

The decision puts Tecentriq on course to be the first checkpoint inhibitor approved in this setting in Europe, following its lead established with an FDA approval in March.

Among other positive news was La Jolla Pharmaceutical’s Giapreza, which was recommended for approval for treatment of refractory hypotension in adults with septic or other distributive shock. The drug gained FDA approval in December 2017.

Celgene also received a positive opinion for azacitidine in myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloidleukaemia.

UCB’s Vimpat (lacosamide) also gained a thumbs up in the epilepsy market, with a recommendation in partial-onset seizures with or without secondary generalisation. This most recent indication sees Vimpat continue on its trajectory to blockbuster status, with forecast revenues of €1.4bn by 2022.

However, as the US patent is set to expire in the same year, UCB had been counting on the new drugs in its pipeline to accelerate their development.

On Friday the CHMP’s most notable ruling was a negative opinion for UCB and Amgen’s severe osteoporosis drug Evenity.

AstraZeneca’s Forxiga gained European marketing authorisation to include use in patients with type 2 diabetes at risk of cardiovascular (CV) events. This follows results from its DECLARE-TIMI 58 trial, which compared the effect of Forxiga with placebo on cardiovascular outcomes in adults with type 2 diabetes at risk of cardiovascular events.

The company also received a positive opinion for a new self-administration option for Fasenra (benralizumab) via a pre-filled, single-use auto-injector, rivalling similar moves from GSK and its Nucala.

This CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation.

1st July 2019

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