The Food and Drug Administration (FDA) has given green signal to Gilead Sciences for its drug idelalisib (Zydelig) for treating three types of relapse lymphoma, one of the forms of blood cancer.
While announcing the decision, Richard Pazdur of FDA said that Zydelig (idelalisib) is the third drug which has been approved with an advance designation for treating CLL patients. Moreover, this is the fifth drug overall to receive this breakthrough designation.
Earlier, obinutuzumab (Gazyva) received FDA clearance for CLL in November 2013. Another drug ibrutinib (Imbruvica) got FDA approval in February this year followed by ofatumumab (Arzerra) in April.
The drug will now treat chronic lymphocytic leukemia (CLL) in relapsed setting along with rituximab (Rituxan). The other two lymphomas for which the federal agency has given a go ahead to Gilead Sciences are relapsed small lymphocytic lymphoma (SLL) and relapsed follicular B-cell non-Hodgkin lymphoma.
150 mg tablets of Zydelig (idelalisib) will treat the patients suffering from the three mentioned B-cell blood cancers as it is a first-in-class inhibitor of the delta isoform of phosphoinositide 3-kinase (PI3K delta), a protein found in B-cell malignancies which influence the proliferation and migration of cancerous cells.
Pazdur, director of the Office of Hematology and Oncology Products, said in a statement, “In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia.”
“Zydelig’s approval to treat CLL reflects the promise of the breakthrough therapy designation program and represents the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review, and approval,” the statement further said.
It is noteworthy, the federal agency has cautioned against several fatal risks linked to idelalisib including disease like severe diarrhea, colitis, hepatotoxicity, intestinal perforation and pneumonitis.
Gilead (NASDAQ:GILD) Sciences stock prices has moved by 1.13 percent and are trading at $90.34 at the moment.
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