Advanced cases of the disease are not always treatable with surgery and there is currently no medical treatment available. The findings could result in the three-year course of therapy becoming the new standard of care for those patients who are at risk for relapse. Roche said the results highlight the importance of continuing with Avastin after combining Avastin with chemotherapy in this setting.
Xtandi is already approved for patients with mCRPC who have previously received docetaxel chemotherapy. The company says that a more complete data set will be presented at an upcoming scientific meeting. The company submits additional data on two applications to expand Avastin's approved breast cancer uses to include combining the drug with other types of chemotherapy. Overall survival is the study's primary endpoint.
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- USA A few days ahead of the PDUFA action date, the FDA approved Onivyde irinotecan liposome injection , in combination with fluorouracil and leucovorin, to treat patients with advanced pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
Zelboraf is the second new cancer drug approved for melanoma this year that demonstrates an improvement in overall survival Bristol-Myers Squibb's Yervoy, which Roche's drug will compete with, was approved in March. Data from the trial is due in mid The approval was based on data from the phase 3 KEYNOTE study in which patients with unresectable or metastatic melanoma who were treated with Keytruda showed superior overall survival OS compared to those treated with ipilimumab.
The phase 3 trial, dubbed STORM, evaluated Nexavar versus placebo as an adjuvant treatment in patients with hepatocellular carcinoma HCC following potential curative treatment surgical resection or local ablation.
According to Amgen's announcement, issued late Tuesday, April 26th, the FDA said it couldn't approve the sBLA in its present form because the effect on bone metastases-free survival didn't outweigh the risks, including osteonecrosis of the jaw, a rare jaw-decay problem.
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- USA Some panelists had concerns over possible side effects including heart and kidney failure. At ASCO, early-stage trial data was positive for the drug in treating pediatric brain tumors. According to the lead investigator, the trial design is unique since it is the first trial in soft tissue sarcoma to compare a single agent to five of the most commonly used treatment options.
A required post-approval study combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients aged with previously untreated AML. Daratumumab had been designated as a Breakthrough Therapy for this patient population.
The study data highlighted the safety and efficacy of sequential administration of sapacitabine and decitabine in elderly patients with AML. The FDA approved Takeda's Ninlaro for multiple myeloma patients who have received one or more prior therapies.
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