FDA approves first chemotherapy-free combo for CLL, SLL

AbbVie Inc. (NYSE:ABBV) and partner Johnson & Johnson (NYSE:JNJ) said FDA approved an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab for treatment-naïve adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The regimen is the first chemotherapy-free combination approved by FDA for the indications, according to J&J.

Imbruvica, an inhibitor of Bruton’s tyrosine kinase (Btk) that AbbVie markets jointly with J&J, is already approved as monotherapy to treat CLL and SLL in all lines of therapy. Roche (SIX:ROG; OTCQX:RHHBY) and Biogen Inc. (NASDAQ:BIIB) market Gazyva, a glycoengineered humanized mAb against CD20, in combination with chemotherapy for CLL in previously untreated patients...