Gilead's Zydelig can stay on the market after trial deaths, EMA concludes

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Gilead cancer drug Zydelig--flagged earlier this year after serious adverse events cropped up in studies--can stay on the market with some new recommendations, European regulators have concluded. But the major damage to the drug’s sales potential has already been done. 

On Friday, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up its review of the blood cancer-fighter, confirming that the med’s benefits outweigh its risks. But the product still carries a risk of series infections, including Pneumocystis jirovecii pneumonia, and patients should receive antibiotics during treatment and for 2 to 6 months after getting Zydelig, the committee said.

The EMA put Zydelig under the lens in March, citing an increase in the rate of serious adverse events--including deaths, mostly due to infections--in three clinical trials examining unapproved med combos and patients with disease characteristics not covered by the drug’s label. And shortly thereafter, Gilead ($GILD) put the kibosh on 6 trials aimed at taking Zydelig--approved for patients who have relapsed after previous treatment--into the first-line setting.

The events put a serious dent in Gilead’s hopes for Zydelig expansion. A first-line nod is a lucrative get for cancer drugmakers; newly approved patients represent a larger patient pool, and they generally stay on therapy for longer periods of time. 

And the roadblock certainly won’t help Zydelig compete against some serious competition--specifically Johnson & Johnson ($JNJ) and AbbVie ($ABBV) star Imbruvica, which snagged its own first-line chronic lymphocytic leukemia nod in March.

"These decisions by Gilead and the regulators effectively mean that Zydelig is dead in the water since it can no longer be used in the preferred combinations and in the most common patient populations,” Leerink Partners analyst Geoffrey Porges wrote in a note to investors at the time. “It also finally resolves the Zydelig vs Imbruvica debate--clearly in favor of Imbruvica."

Gilead did get some good news out of Europe to end the week, though. It nabbed a green light for hep C med Epclusa, an all-genotype therapy that won FDA favor late last month.

- read the EMA's recommendation (PDF)

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