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FDA begins speedy review of Celgene’s Revlimid combo in lymphoma

R2 met its primary endpoint of PFS in trials

Celgene

The FDA has begun a priority review of Celgene’s blood cancer blockbuster Revlimid in combination with Roche’s Rituxan as a potential treatment for those with lymphoma.

Known as R2, the combination is being evaluated for those with previously treated follicular and marginal zone lymphoma, and if approved, the therapy could free patients of chemotherapy.

“R2 has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy free option”, said Jay Backstrom, chief medical officer and Head of Global Regulatory Affairs for Celgene.

“We look forward to working with the FDA to bring the R2 regimen to patients as quickly as possible.”

The regimen checked out in the AUGMENT trial, with the company reporting that it met its primary endpoint of progression-free survival, doubling the median PFS over the Rituxan and placebo combo.

It also met the secondary endpoint of overall survival, with only 16 death events reported in the Revlimid combo group versus 26 death events in the comparator arm.

These results wildly contrasted to a previous set of phase 3 data, which saw the same combination being tested as a first line treatment in those with follicular lymphoma (a subtype of non-Hodgkin’s lymphoma), but failed to show any benefit in these patients compared to Rituxan and chemotherapy (current standard of care).

Nevertheless, the recent results came at a much-welcomed relief for both Celgene and Bristol Myers Squibb, which announced a $74 billion takeover of Celgene.

That decision was  prompted by Revlimid’s success, which is Celgene’s top-selling drug, bringing in $9.7bn last year – an increase of 18% year-over-year.

An approval in FL and MZL would mean an expanded NSL patient group, and of course, boosted earnings. The FDA will make its decision by 27 June.

Meanwhile, Celgene announced an updated timing on its Biologics License Application (BLA) for its new product luspatercept as a treatment for those with anemia related to very low to intermediate myelodysplastic syndromes (MDS) and those with anemia related to beta-thalassemia.

Although not a cure for beta-thalassemia, the drug has been tipped as a potential blockbuster for Celgene. It's one of five new drugs that Celgene aims to launch through 2020, and the company hopes these new products could offset its reliance on Revlimid.

Article by
Gemma Jones

27th February 2019

From: Sales

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