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J&J gets CHMP backing for broader Darzalex use

Recommendation for earlier-stage approval could see multiple myeloma drug reach blockbuster sales
Johnson & Johnson

Janssen-Cilag has moved closer to an expanded label in the EU for its multiple myeloma drug Darzalex, allowing patients with earlier-stage disease to receive the drug.

The EMA's Committee for Medicinal Products for Human Use (CHMP) backed Darzalex (daratumumab) for use in combination with two standard regimens in adult multiple myeloma patients who have received at least one prior therapy.

The Johnson & Johnson (J&J) unit's first-in-class anti-CD38 antibody was given conditional approval in the EU last May as a monotherapy after both the two standard therapies - Celgene's Revlimid (lenalidomide) plus dexamethasone and Takeda's Velcade (bortezomib) plus dexamethasone - have already been tried.

The new indication - which has also been approved in the US - takes Darzalex another step forward towards what some analysts have predicted could be sales of almost $5bn in the next five years, despite an increasingly crowded multiple myeloma market.

Takeda's orally-active proteasome inhibitor Ninlaro (ixazomib), Novartis' HDAC inhibitor Farydak (panobinostat) and Bristol-Myers Squibb's SLAMF7 inhibitor Empliciti (elotuzumab) are all jostling for market share with Darzalex at the moment. J&J's drug is off to a good start however, with sales of $572m last year, ahead of analysts' predictions.

"Daratumumab has already demonstrated single-agent efficacy in highly refractory patients," said Torben Plesner of Vejle Hospital in Denmark, who was involved in the CASTOR and POLLUX clinical trials, which underpin the new regulatory submission.

"Now, consistent with these data, the results when used in combination with standard-of-care regimens after one prior line of therapy are also encouraging," he added.

New products are expected to help drive the global market for multiple myeloma therapies from $8.9bn in 2014 to an estimated $22.4bn by 2023, according to GlobalData.

CHMP round-up
At its meeting last week the CHMP also gave its blessing to the combination of Novartis' Tafinlar (dabrafenib) and Mekinist (trametinib) in BRAF-positive non-small cell lung cancer (NSCLC) patients which - if approved by the EMA - will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation.

Tesaro picked up a positive opinion for Varuby (rolapitant), an oral substance P/neurokinin-1 (NK-1) receptor antagonist for treating chemotherapy-induced nausea and vomiting, and Shire got the go-ahead for Natpara (parathyroid hormone), a treatment for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard treatment with calcium and vitamin D.

Article by
Phil Taylor

27th February 2017

From: Regulatory



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