Gilead’s (GILD) Kite has announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy.
Yescarta was previously granted Breakthrough Therapy Designation (BTD) by the FDA for these indications.
If approved, Yescarta would become the first chimeric antigen receptor (CAR) T cell therapy approved for the treatment of relapsed or refractory indolent non-Hodgkin lymphoma (NHL).
Follicular lymphoma and marginal zone lymphoma are both forms of indolent non-Hodgkin lymphoma in which malignant tumors slowly grow but can become more aggressive over time.
The sBLA submission is supported by data from the primary analysis of the ongoing Phase 2 ZUMA-5 trial, which is being submitted for presentation at an upcoming scientific congress. The primary endpoint of the trial is objective response rate (ORR) as assessed by an independent review committee.
“People living with indolent NHL often experience a disease that starts out slowly but becomes more aggressive over time with each subsequent relapse,” commented Kite’s Ken Takeshita.
“The efficacy observed in ZUMA-5 may provide a potentially transformative treatment option for higher-risk patients with certain types of indolent NHL” he continued.
Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Currently, there are no standard of care treatments for relapsed and refractory follicular lymphoma after two or more lines of therapy, and there are limited options for the treatment of relapsed or refractory marginal zone lymphoma.
Shares of GILD are currently trading up 2% year-to-date, and the stock scores a cautiously optimistic Moderate Buy consensus from the Street. That’s with an average analyst price target of $78, indicating 18% upside potential from current levels.
Mizuho Securities analyst Salim Syed is bullish on GILD’s outlook, even after it announced that its rheumatoid arthritis drug, filgotinib, which was under FDA review for marketing approval, received a complete response letter (i.e. a rejection because the FDA needs more data).
He reiterated a buy rating on the stock with an $81 price target on August 19, arguing that US filgotinib revenue in 2020 not super material (i.e. not much built in for 2020). (See Gilead stock analysis on TipRanks)
“We have been of the opinion that filgotinib could be the best-in-class JAK1 inhibitor, and while this CRL leads us to moderate our filgotinib sales expectations going forward (US approval from 2020 to late 2021E), it does not dim our enthusiasm for the drug” added Oppenheimer analyst Hartaj Singh.
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