FDA Review of Previously-Rejected Arthritis Drug comes with conditions
FDA is reconsidering approval for previously rejected arthritis drug by Eli Lilly and Incyte. However, the regulators have major safety concerns about the potential for the drug to cause thrombosis. Safety data supported a lower 2 mg dose of the drug but not a 4 mg dose. If the regulators till approve the drug, but it is unlikely to measure up to its previous blockbuster billing.
AstraZeneca wins U.S. approval for 1st-line use of lung cancer drug
Tagrisso (Osimertinib), AstraZeneca’s lung cancer drug, has already been approved for use in patients whose lung cancer worsened after treatment with other EGFR therapies and who have developed a secondary mutation. Tagrisso has shown to provide improvements in progression-free survival with no unexpected safety signals compared to the previous generations of EGFR inhibitors. Tagrisso has been designed for patients with certain EGFR mutations which can hold the disease at bay, however, cancer cells often adapt and develop new resistance mechanisms.
FDA has expanded Tagrisso’s use to include initial treatment of patients with a specific genetic mutation in patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations detected using an FDA-approved test. The drug is currently under review by the European union and Japan.
FDA Approved IO Combo for Advanced Renal Cell Cancer
The USFDA approved the immune-oncology (IO) combination of nivolumab and ipilimumab as an initial treatment for advanced renal cell carcinoma (RCC) with intermediate or poor risk.
The approval came from findings of a randomized open label trial of 1,082 patients with previously untreated advanced RCC to receive nivolumab plus ipilimumab followed by nivolumab maintenance therapy or sunitinib (Sutent, Pfizer), which is considered the standard of care. The trial showcased statistically significant improvements in overall survival and objective response rate for patients receiving the combination compared to those receiving only sunitinib.
However, the efficacy of the combination in patients with favorable risk disease was not established. Therefore, the combination is not approved for favorable risk patients, but is approved for use in intermediate or poor risk patients.
In the pivotal trial, the combination was associated with fewer overall grade 3 or 4 adverse events than sunitinib (65% vs 76%). However, treatment discontinuation due to adverse events occurred in 31% of patients in the combination IO arm, compared to 21% in the sunitinib arm.
The FDA granted the applications for each of the drugs in the combination a priority review and breakthrough therapy designation.
Lilly’s Cyramza succeeds in late-stage liver cancer trial
Eli Lilly’s cancer already approved drug Cyramza that helps liver cancer patients live longer is now being tested as a single therapy for a new indication of hepatocellular carcinoma.
Patients previously intolerant to or worsened despite treatment with Bayer’s targeted cancer drug Nexavar were tested with Cyramza. The drug also seems to have met a secondary goal of delaying progression of the disease.
The estimated sale could reach $960 million by 2021 as per BMO Capital Markets analysts.
European Label expanded for Amgen’s Xgeva
Amgen’s Xgeva, earlier approved for inhibiting bone issues in patients treated for solid tumors, has been approved by the European Commission for the prevention of skeletal complications in patients with multiple myeloma, a bone marrow cancer. The label of the drug has been updated to include the treatment of US-based multiple myeloma patients, which was then approved by the FDA. The label was approved based on clinical trial that compared the efficacy of the Xgeva with zoledronic acid, which is the first line of treatment for preventing fractures and other bone related complications in patients with multiple myeloma. More than 1700 patients participated in the study, which concluded that Xgeva was at par with zoledronic acid in preventing incidence of bone related complications. As per Amgen the overall survival was comparable between the two drugs. The expansion of the label resulted in stock price gain.
Sunovion submits Parkinson’s drug application
Sunovion has applied for the approval of a fast-acting drug to treat motor fluctuations, or OFF episodes, in Parkinson’s disease patients. Studies have shown that the drug has superior efficacy versus its placebo, for the on-demand treatment of OFF episode, with the drugs’s effect persisting for at least 90 minutes. The drug has already received fast tract designation by the FDA.