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CHMP backs Bayer’s tumour-agnostic drug Vitrakvi

GW Pharma’s Epidyolex also on the recommended list


Bayer’s Vitrakvi has become the first drug in Europe recommended to treat cancer based on a molecular signature, rather than where it originated in the body.

The EMA’s human medicines committee (CHMP) has backed a conditional approval of Vitrakvi (larotrectinib) for the treatment of solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

The ‘histology-independent’ treatment should be used for patients whose disease has spread or cannot be surgically removed, and who have no other satisfactory treatment options, says the CHMP.  NTRK fusions occur in around 1% of all solid tumours.

Vitrakvi – originally developed by Loxo Oncology - was approved in the US for NTRK fusion tumours last November, and has also been given the green light in Canada and Brazil.

The two partners are trying to build a lead in both markets over Roche’s rival drug entrectinib, currently being reviewed by the FDA as a second-line option after Vitrakvi, although Roche is aiming to advance it into first-line use. Entrectinib has just been approved in Japan, its first market, as Rozlytrek.

The CHMP has also granted a positive opinion for GW Pharma’s Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two severe forms of epilepsy. The drug was also approved in the US last year as Epidiolex, becoming the first ever prescription medicine derived from cannabis.

There were two other positive opinions on new medicines at the CHMP meeting last week, with the panel backing Acorda Therapeutics’ inhaled Inbrija (levodopa) for the treatment of symptoms of ‘off’ periods in Parkinson’s disease, as well as Theratechnologies’ Trogarzo (ibalizumab) as an add-on treatment for drug resistant HIV.

The committee also recommended a new generic from Mylan of Novartis’ Exjade (deferasirox), which is used to treat chronic iron overload due to blood transfusions in patients with beta thalassaemia, non-transfusion-dependent thalassaemia syndromes and other anaemias. Exjade made sales of more than $1bn last year.

The latest meeting also included a number of line extensions. Among these, Roche got the nod for a new indication for its cancer immunotherapy Tecentriq (atezolizumab) in non-small cell lung cancer, namely use in combination with chemotherapy (carboplatin/nab-paclitaxel) for previously-untreated patients with non-squamous NSCLC.

The approval, based on the results of the IMpower130 trial, could help Roche try to build in first-line NSCLC, an indication dominated by Merck & Co’s Keytruda (pembrolizumab). That will be an uphill battle, however, particularly as another Tecentriq/chemo combination missed the mark in a trial reported last year.

Merck picked up another positive opinion for Keytruda, this time for use alongside Pfizer’s targeted cancer drug Inlyta (axitinib) for first-line treatment of renal cell carcinoma, and Bristol-Myers Squibb got the go-ahead for Empliciti (elotuzumab) alongside Celgene’s Pomalyst (pomalidomide) and dexamethasone for relapsed/refractory multiple myeloma, based on the ELOQUENT-3 trial.

Empliciti was approved in the US for this indication with a breakthrough designation from the FDA last year.

The CHMP also said it has agreed to re-examine Amgen’s osteoporosis drug Evenity (romosozumab) after issuing a negative opinion at its June meeting, and is also taking a fresh look at two other recent rejections – Novartis’ Revolade (eltrombopag) for severe aplastic anaemia and PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna (ataluren).

Finally, the panel recommended that Novartis’ multiple sclerosis drug Gilenya (fingolimod) should not be used in pregnant women and in women able to have children who are not using effective contraception because of a risk of birth defects.

Article by
Phil Taylor

29th July 2019

From: Regulatory



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