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Bayer Aktiengesellschaft BAYRY announced that it has submitted a supplemental new drug application (sNDA) to the FDA, seeking approval of its marketed drug, Aliqopa (copanlisib) in combination with Roche’s RHHBY Rituxan (rituximab) for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (B-iNHL).
Simultaneously, Bayer also submitted a marketing authorization application or MAA to the European Medicines Agency (EMA), seeking approval of the novel combination of Aliqopa plus Rituxan for the treatment of relapsed marginal zone lymphoma (“MZL”), a subtype of iNHL.
Both U.S. and the EU filings were based on positive data from the double-blind, placebo-controlled phase III CHRONOS-3 study. The aim of the study was to check whether the combo of Aliqopa+Rituxan was superior to placebo plus rituximab in extending progression-free survival (“PFS”) in patients with relapsed iNHLafter one prior rituximab-containing therapy.
Data from the study showed that treatment with the combo of Aliqopa plus Rituxan (given intravenously) led to a significant improvement in PFS – the primary endpoint – as compared to the combination of rituximab and placebo.
Upon potential approval, the combo of Aliqopa plus Rituxan can provide a new treatment option for patients with different types of relapsed indolent non-Hodgkin’s lymphoma, thereby serving an area of unmet medical need.
Shares of Bayer have rallied 5.2% so far this year compared with the industry’s rise of 7%.
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We note that Aliqopa, a PI3K inhibitor, is already approved as a monotherapy for the treatment of relapsed follicular lymphoma (FL) in adult patients who have received at least two prior systemic therapiesin the United States, Israel and Taiwan. A potential label expansion will help the drug gain access to a broader patient population and consequently drive sales in the days ahead.
The FDA has granted Orphan Drug designation to Aliqopa for the treatment of FL and MZL as well as other types of lymphomas. The drug has received a breakthrough therapy designation in the United States and China for MZL.
Please note that the phase III CHRONOS-4 study is evaluating Aliqopa in combination with standard immunochemotherapy for the treatment of relapsed iNHL.
Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the healthcare sector include Repligen Corporation RGEN and Bio-Techne Corporation TECH, both carrying the same Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 18.3% and 14.7% upward for 2021 and 2022, respectively, over the past 60 days. The stock has rallied 2.4% year to date.
Bio-Techne’s earnings estimates have been revised upward by 8.8% and 9.1% for 2021 and 2022, respectively, over the past 60 days. The stock has surged 38.6% year to date.
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Roche Holding AG (RHHBY) : Free Stock Analysis Report
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