Cancer Space Roundup: NVS' Tasigna & SGEN's Adcetris Label Expansions In Focus
Zacks Investment Research | Mar 22, 2018 10:28PM ET
The cancer space saw label expansion of two major drugs this week. Seattle Genetics, Inc.’s (NASDAQ:SGEN) , Adcetris label was expanded to include treatment naive patients with advanced Hodgkin lymphoma (cHL). Novartis’ (NYSE:NVS) Tasigna received approval for use in pediatric patients, one year of age or older.
Meanwhile, the FDA granted priority review to Pfizer’s (NYSE:PFE) regulatory application seeking label expansion of Xtandi to include an early-stage patient population. Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) PD-L1 inhibitor, Tecentriq, met primary endpoint in a phase III lung cancer combination study. However, AbbVie (NYSE:ABBV) announced disappointing results from a mid-stage study evaluating its lung cancer candidate, Rovalpituzumab Tesirine (Rova-T).
Let’s see the news in details.
Seattle Genetics’ Adcetris Label Expansion: The FDA approved a supplemental Biologics License Application (sBLA) seeking label expansion of Seattle Genetics’ Adcetris in treatment-naive stage III or IV cHL patients. The drug was approved in combination with a chemotherapy regimen, AVD (Adriamycin, vinblastine and dacarbazine), based on statistically significant improvement in progression-free survival data from phase III ECHELON-1 study. The study compared Adcetris combination regimen with the current standard of care. (Read more: Seattle Genetics' Adcetris Gets FDA Nod for Label Expansion ).
Novartis’s Tasigna Label Expanded in Pediatric Patients: Novartis announced that the FDA has approved a line extension of its leukemia drug, Tasigna, in pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. The drug received approval in first- and second-line setting in this patient population. The drug is already available for adults in this indication.
The approval was based on data from two studies evaluating Tasigna in patients in the age group of 2 years to 18 years. Data showed that the major molecular response (MMR) rate was 60% and 40.9% in newly diagnosed patients and patients resistant to prior therapy, respectively.
Novartis AG Price
Pfizer's Xtandi Label Expansion Filing Gets Priority Review ).
Pfizer Inc. Price
Roche Tecentriq Phase III Combo Study Meets Primary Endpoint ).
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AbbVie Stock Falls on Weak Lung Cancer Study Outcome )
During the week, AbbVie collaborated with the International Myeloma Foundation to conduct a landmark retrospective chart review study. The study will evaluate the overall survival of patients with multiple myeloma.
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