The
European Medicines Agency (EMA) committee released the results of a
safety review for Gilead’s blood cancer drug Zydelig on Friday.
Zydelig gained regulatory approval in the EU for treating two different types of blood cancer, chronic lymphocytic leukemia and follicular lymphoma.
“The review was started after a higher rate of serious adverse events related to infections, such as pneumonia, was seen in three clinical trials among patients who received either Zydelig or placebo (a dummy treatment) in addition to other cancer medicines,” according to the EMA’s guidance.
Furthermore, Gilead ceased another six trials that focused on Zydelig’s potency as a first-line treatment.
The EMA’s review acknowledged that Zydelig would benefit patients diagnosed with the aforementioned approved conditions.
However, it recommended that patients be prescribed a regimen of antibiotics during this treatment period and continuing it for at least two to six months at the conclusion of this timeframe.
Also, the review noted physicians should conduct regular blood tests for white cell counts along with monitoring for signs of any infection.
This decision will impact sales prospects for Gilead, reported FiercePharma. A label expansion for a first-line treatment would have allowed Gilead to offer this drug to a larger group of patients who would have needed this therapy for an extended period of time.
J&J’s Imbruvica could fill that space since it was granted approval for first-line chronic lymphocytic leukemia earlier this year.
Zydelig gained regulatory approval in the EU for treating two different types of blood cancer, chronic lymphocytic leukemia and follicular lymphoma.
“The review was started after a higher rate of serious adverse events related to infections, such as pneumonia, was seen in three clinical trials among patients who received either Zydelig or placebo (a dummy treatment) in addition to other cancer medicines,” according to the EMA’s guidance.
Furthermore, Gilead ceased another six trials that focused on Zydelig’s potency as a first-line treatment.
The EMA’s review acknowledged that Zydelig would benefit patients diagnosed with the aforementioned approved conditions.
However, it recommended that patients be prescribed a regimen of antibiotics during this treatment period and continuing it for at least two to six months at the conclusion of this timeframe.
Also, the review noted physicians should conduct regular blood tests for white cell counts along with monitoring for signs of any infection.
This decision will impact sales prospects for Gilead, reported FiercePharma. A label expansion for a first-line treatment would have allowed Gilead to offer this drug to a larger group of patients who would have needed this therapy for an extended period of time.
J&J’s Imbruvica could fill that space since it was granted approval for first-line chronic lymphocytic leukemia earlier this year.
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