May 1, 2018 / 8:36 PM / 2 months ago

BRIEF-Novartis says Kymriah receives second FDA approval

May 1 (Reuters) - Novartis AG:

* KYMRIAH® (TISAGENLECLEUCEL), FIRST-IN-CLASS CAR-T THERAPY FROM NOVARTIS, RECEIVES SECOND FDA APPROVAL TO TREAT APPROPRIATE R/R PATIENTS WITH LARGE B-CELL LYMPHOMA

* US FOOD AND DRUG ADMINISTRATION APPROVED KYMRIAH SUSPENSION FOR INTRAVENOUS INFUSION FOR ITS SECOND INDICATION

* KYMRIAH DEMONSTRATED OVERALL RESPONSE RATE OF 50%, WITH MEDIAN DURATION OF RESPONSE NOT YET REACHED AT TIME OF DATA CUT-OFF

* KYMRIAH IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA Source text for Eikon: Further company coverage:

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