The cancer space saw label expansion of two major drugs this week. Seattle Genetics, Inc.’s SGEN, Adcetris label was expanded to include treatment naive patients with advanced Hodgkin lymphoma (cHL). Novartis’ NVS Tasigna received approval for use in pediatric patients, one year of age or older.
Meanwhile, the FDA granted priority review to Pfizer’s PFE regulatory application seeking label expansion of Xtandi to include an early-stage patient population. Roche Holding AG’s RHHBY PD-L1 inhibitor, Tecentriq, met primary endpoint in a phase III lung cancer combination study. However, AbbVie 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.
Pfizer’s sBLA for Xtandi Gets Priority Review: The FDA granted priority review to a sBLA for Pfizer’s prostate cancer drug, Xtandi. Pfizer is looking to include the non-metastatic Castration-Resistant Prostate Cancer indication in the drug’s label. The regulatory status was granted based on data from the phase III PROSPER study. A decision from the FDA is expected in July this year. (Read more: Pfizer's Xtandi Label Expansion Filing Gets Priority Review).
Roche’s Tecentriq Meets Primary Endpoint: Roche’s subsidiary Genentech announced that Tecentriq in combination with chemotherapy (carboplatin and Abraxane) reduced the risk of disease worsening or death compared with chemotherapy alone in the phase III IMpower131 study. The study was evaluating the combo regimen in patients with advanced squamous non-small cell lung cancer. However, the study will be continued as statistically significant overall survival benefit was not achieved. (Read more: Roche Tecentriq Phase III Combo Study Meets Primary Endpoint).
AbbVie’s Rova-T Fails in Phase II Study: AbbVie shares crashed on Thursday, following the announcement of disappointing results from a pivotal phase II study evaluating Rova-T in third-line or later small cell lung cancer. The study evaluated the candidate in SCLC patients with high expression of the protein DLL3 and who have received at least two previous treatment regimens, including at least one platinum-based regimen.
The results did not meet expectations and were not significant enough for the candidate to be prioritized for accelerated approval. However, two phase III studies evaluating Rova-T in first- and second-line settings for the SCLC are ongoing. (Read more: 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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