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Lilly (LLY) Gets CRL from FDA for Sintilimab in Lung Cancer
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Eli Lilly and Company (LLY - Free Report) announced that the FDA has issued a complete response letter (“CRL”) to the biologics license application (“BLA”) seeking approval for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer (“NSCLC”).
In May 2021, the FDA accepted for review the BLA for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous NSCLC. A decision from the regulatory body was expected in March 2022.
The BLA filing was based on data from the phase III ORIENT-11 study.
Per the press release, the latest CRL confirms that the review cycle for the application is complete. However, the FDA will not be able to approve the same in its current form owing to the outcome of the Oncologic Drugs Advisory Committee (“ODAC”) meeting held in February 2022.
The CRL recommends an additional clinical study, specifically a multiregional clinical one, which will compare standard-of-care therapy for first-line metastatic NSCLC to sintilimab with chemotherapy using a non-inferiority design, and with an endpoint of overall survival.
The new study is likely to delay the approval of sintilimab in the United States.
In February 2022, the FDA’s ODAC voted against approving Lilly’s BLA for sintilimab. The ODAC voted that Lilly and its partner, Innovent, should conduct an additional study for seeking approval of sintilimab in the United States.
The ODAC meeting was convened to discuss the concerns related to approval of the sintilimab BLA by the FDA based on single-country foreign data. Although the ORIENT-11 study met its primary endpoint of progression free survival (“PFS”), the ODAC concluded that Lilly and Innovent’s study in China was insufficient to support U.S. approval.
The ODAC pointed out that multiregional clinical studies are the preferred international standard for drug development as these can represent a diverse patient population. Data from these studies can help conclusively evaluate the consistency of a drug’s effectiveness across geographic regions. The ODAC also pointed out that Innovent had no discussion with the FDA while designing the ORIENT-11 study. The study’s primary endpoint was PFS. However, the FDA-preferred primary endpoint for a lung cancer study is overall survival. The ODAC concluded that the ORIENT-11 study does not effectively represent the diverse ethnic subgroups within the U.S. population.
Lilly and Innovent remain focused to work with the FDA to complete the review of the sintilimab application.
Shares of Lilly have rallied 4.2% so far this year compared with the industry’s growth of 1.5%.
Image Source: Zacks Investment Research
Sintilimab, a PD-1 inhibitor, is marketed under the brand name Tyvyt in China by Lilly in collaboration with the country’s biopharmaceutical company, Innovent.
Tyvyt is approved in China for addressing second or later-line relapsed or refractory classic Hodgkin's lymphoma and also for first-line treatment of nonsquamous as well as squamous NSCLC. The drug is also approved for first-line treatment of hepatocellular carcinoma.
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank of #3 (Hold). Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’searnings estimates have been revised 20.5% upward for 2022 and 27.9% for 2023 over the past 60 days. The INVA stock has rallied 13.9% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% for 2023 over the past 60 days. The COLL stock has gained 2.3% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 8.7% upward for 2022 and 8.4% upward for 2023 over the past 60 days. The VRTX stock has increased 14.6% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.
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Lilly (LLY) Gets CRL from FDA for Sintilimab in Lung Cancer
Eli Lilly and Company (LLY - Free Report) announced that the FDA has issued a complete response letter (“CRL”) to the biologics license application (“BLA”) seeking approval for sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer (“NSCLC”).
In May 2021, the FDA accepted for review the BLA for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous NSCLC. A decision from the regulatory body was expected in March 2022.
The BLA filing was based on data from the phase III ORIENT-11 study.
Per the press release, the latest CRL confirms that the review cycle for the application is complete. However, the FDA will not be able to approve the same in its current form owing to the outcome of the Oncologic Drugs Advisory Committee (“ODAC”) meeting held in February 2022.
The CRL recommends an additional clinical study, specifically a multiregional clinical one, which will compare standard-of-care therapy for first-line metastatic NSCLC to sintilimab with chemotherapy using a non-inferiority design, and with an endpoint of overall survival.
The new study is likely to delay the approval of sintilimab in the United States.
In February 2022, the FDA’s ODAC voted against approving Lilly’s BLA for sintilimab. The ODAC voted that Lilly and its partner, Innovent, should conduct an additional study for seeking approval of sintilimab in the United States.
The ODAC meeting was convened to discuss the concerns related to approval of the sintilimab BLA by the FDA based on single-country foreign data. Although the ORIENT-11 study met its primary endpoint of progression free survival (“PFS”), the ODAC concluded that Lilly and Innovent’s study in China was insufficient to support U.S. approval.
The ODAC pointed out that multiregional clinical studies are the preferred international standard for drug development as these can represent a diverse patient population. Data from these studies can help conclusively evaluate the consistency of a drug’s effectiveness across geographic regions. The ODAC also pointed out that Innovent had no discussion with the FDA while designing the ORIENT-11 study. The study’s primary endpoint was PFS. However, the FDA-preferred primary endpoint for a lung cancer study is overall survival. The ODAC concluded that the ORIENT-11 study does not effectively represent the diverse ethnic subgroups within the U.S. population.
Lilly and Innovent remain focused to work with the FDA to complete the review of the sintilimab application.
Shares of Lilly have rallied 4.2% so far this year compared with the industry’s growth of 1.5%.
Image Source: Zacks Investment Research
Sintilimab, a PD-1 inhibitor, is marketed under the brand name Tyvyt in China by Lilly in collaboration with the country’s biopharmaceutical company, Innovent.
Tyvyt is approved in China for addressing second or later-line relapsed or refractory classic Hodgkin's lymphoma and also for first-line treatment of nonsquamous as well as squamous NSCLC. The drug is also approved for first-line treatment of hepatocellular carcinoma.
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank of #3 (Hold). Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’searnings estimates have been revised 20.5% upward for 2022 and 27.9% for 2023 over the past 60 days. The INVA stock has rallied 13.9% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% for 2023 over the past 60 days. The COLL stock has gained 2.3% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 8.7% upward for 2022 and 8.4% upward for 2023 over the past 60 days. The VRTX stock has increased 14.6% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.