01:33 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

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...
20:56 , Jan 28, 2019 |  BC Extra  |  Company News

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...
05:08 , Jan 4, 2019 |  BC Week In Review  |  Clinical News

Imbruvica, Gazyva combo reduces disease progression or death by 77% in Phase III for first-line CLL

AbbVie Inc. (NYSE:ABBV) reported additional data from the Phase III iLLUMINATE (PCYC-1130) trial to treat previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) showing that Imbruvica ibrutinib plus Gazyva obinutuzumab reduced the...
02:33 , Dec 8, 2018 |  BioCentury  |  Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
18:31 , Dec 7, 2018 |  BC Week In Review  |  Clinical News

Regeneron planning Phase II for REGN1979 in lymphoma following ASH readout

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) plans to start next year a "potentially registrational" Phase II trial of REGN1979 to treat relapsed or refractory follicular lymphoma after reporting an overall response rate (ORR) of 100% in a...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
21:41 , Nov 28, 2018 |  BC Extra  |  Company News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
17:33 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Venclexta/Gazyva combo meets PFS endpoint in Phase III for first-line CLL

Genentech Inc. and AbbVie Inc. (NYSE:ABBV) said first-line treatment with Venclexta venetoclax plus Gazyva obinutuzumab met the primary endpoint of improving investigator-assessed progression-free survival (PFS) compared with Gazyva plus chlorambucil in the Phase III CLL14...
18:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS;...