Bayer, Novo separately opt to discontinue their Aliqopa, Levemir
Bayer said it will voluntarily withdraw its follicular lymphoma drug Aliqopa from the US after a confirmatory trial disappointment, marking the third PI3K inhibitor to be pulled in recent years.
Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational combination of the cancer treatments Aliqopa® (copanlisib) and rituximab.
WHIPPANY, N.J.--(BUSINESS WIRE)--Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa® (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study.1 The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology.
WHIPPANY, N.J.--(BUSINESS WIRE)--Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa® (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study.1 The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology.
Netherlands-based group Pharming has in-licensed for $20 million an experimental rare-disease drug from Novartis called leniolisib, which is part of a drug class more typically advanced for oncology indications.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Aliqopa (copanlisib).
About a month after the publication of encouraging results from an early-stage study evaluating J&J’s Imbruvica in combination with its experimental drug umbralisib, TG Therapeutics on Tuesday said the drug has been granted the FDA’s breakthrough therapy status for use in patients with marginal zone lymphoma (MZL), a type of cancer with no specifically approved therapies.
Novartis has positive phase III results in hand for its PI3K inhibitor alpelisib in advanced breast cancer patients, which it hopes will be enough to file for regulatory approvals.
ZURICH (Reuters) - Novartis’s efforts to tackle an elusive gene mutation behind tough-to-treat breast cancer were rewarded on Thursday, as the Swiss drugmaker said one of its investigational medicines slowed disease progression.