FDA

FDA adds two Roche studies to its growing list of partial clinical holds in wake of Keytruda deaths

Alarmed that an imbalance in deaths among patients taking a combination of Keytruda with Celgene’s Pomalyst and Revlimid could represent a threat in that whole class of checkpoint combos, the FDA has added two Tecentriq studies to its growing list of clinical trials placed on partial hold.

Now Roche’s Phase Ib and a Phase Ib/II in relapsed/refractory multiple myeloma and relapsed/refractory follicular lymphoma will stop enrolling new patients, though the volunteers who have already signed up can continue.

In a statement, Roche says it’s seen no evidence of the same safety threat that forced a halt to a slate of three Keytruda combination studies at Merck in early July.

Just a few days ago regulators ordered a similar freeze on enrolling new patients in Bristol-Myers Squibb’s three rival studies concentrating on the same disease with the same combination approaches. And hours later Celgene $CELG added that it is being forced to pause five combo studies using AstraZeneca’s Imfinzi while getting slammed with a full hold on one other.

The FDA has gone to some pains to outline its safety worries and provide a careful assessment of what’s been happening. With five PD-(L)1 drugs now on the market, though, hundreds of additional studies are ongoing for combination approaches to treating cancer.


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