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Lilly's Cyramza Gets CHMP Recommendation for First-Line NSCLC
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Eli Lilly and Company (LLY - Free Report) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) recommended the approval of label expansion for Cyramza (ramucirumab) in first-line metastatic non-small cell lung cancer (“NSCLC”) with EGFR mutation. The company is seeking an approval for the multi-cancer drug in combination with Roche’s (RHHBY - Free Report) Tarceva (erlotinib) in this indication in Europe.
The positive CHMP opinion was based on data from the phase III RELAY study evaluating Cyramza plus Tarceva in previously untreated patients with metastatic NSCLC whose tumors have activating EGFR mutations. Data from the study has demonstrated that the combination regimen has significantly improved progression-free survival.
We note that the European Commission generally considers the CHMP recommendation while approving a drug but isn’t bound by it. If approved, sales of the drug will likely get a significant boost as there is a large number of patients with first-line lung cancer. Per the press release, nearly 470,000 patients are diagnosed with the disease every year in Europe.
The company has also submitted regulatory applications seeking similar label expansion for the Cyramza combination regimen in the United States and Japan. A decision in these countries is expected next year.
Please note that Cyramza is already approved in combination with chemotherapy, docetaxel, for treating metastatic NSCLC patients whose cancer has progressed after prior platinum-based chemotherapy. The drug is also approved as monotherapy on in combination with other drugs for second-line gastric, liver and colorectal cancer. Lilly is also developing Cyramza in combination with other anti-cancer therapies for the treatment of multiple tumor types.
While the NSCLC market presents immense potential, competition is stiff in this space. In April 2019, Pfizer’s (PFE - Free Report) Vizimpro was approved for treating previously untreated EGFR-mutated NSCLC patients in Europe. Several other therapies are also approved for treating similar indication including AstraZeneca’s (AZN - Free Report) Tagrisso.
So far this year, Lilly’s shares have gained 8.9% compared with the industry’s rise of 5%.
In a separate press release, Lilly and its partner, Boehringer Ingelheim, announced updated data from two phase III studies, evaluating their diabetes drug, Jardiance, in patients with chronic heart failure with reduced and preserved ejection fraction. Data showed that there was no significant change in exercise ability in patients treated with Jardiance from baseline to week 12 compared to placebo.
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Lilly's Cyramza Gets CHMP Recommendation for First-Line NSCLC
Eli Lilly and Company (LLY - Free Report) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) recommended the approval of label expansion for Cyramza (ramucirumab) in first-line metastatic non-small cell lung cancer (“NSCLC”) with EGFR mutation. The company is seeking an approval for the multi-cancer drug in combination with Roche’s (RHHBY - Free Report) Tarceva (erlotinib) in this indication in Europe.
The positive CHMP opinion was based on data from the phase III RELAY study evaluating Cyramza plus Tarceva in previously untreated patients with metastatic NSCLC whose tumors have activating EGFR mutations. Data from the study has demonstrated that the combination regimen has significantly improved progression-free survival.
We note that the European Commission generally considers the CHMP recommendation while approving a drug but isn’t bound by it. If approved, sales of the drug will likely get a significant boost as there is a large number of patients with first-line lung cancer. Per the press release, nearly 470,000 patients are diagnosed with the disease every year in Europe.
The company has also submitted regulatory applications seeking similar label expansion for the Cyramza combination regimen in the United States and Japan. A decision in these countries is expected next year.
Please note that Cyramza is already approved in combination with chemotherapy, docetaxel, for treating metastatic NSCLC patients whose cancer has progressed after prior platinum-based chemotherapy. The drug is also approved as monotherapy on in combination with other drugs for second-line gastric, liver and colorectal cancer. Lilly is also developing Cyramza in combination with other anti-cancer therapies for the treatment of multiple tumor types.
While the NSCLC market presents immense potential, competition is stiff in this space. In April 2019, Pfizer’s (PFE - Free Report) Vizimpro was approved for treating previously untreated EGFR-mutated NSCLC patients in Europe. Several other therapies are also approved for treating similar indication including AstraZeneca’s (AZN - Free Report) Tagrisso.
So far this year, Lilly’s shares have gained 8.9% compared with the industry’s rise of 5%.
In a separate press release, Lilly and its partner, Boehringer Ingelheim, announced updated data from two phase III studies, evaluating their diabetes drug, Jardiance, in patients with chronic heart failure with reduced and preserved ejection fraction. Data showed that there was no significant change in exercise ability in patients treated with Jardiance from baseline to week 12 compared to placebo.
Eli Lilly and Company Price
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Zacks Rank
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This outperformance has not just been a recent phenomenon. From 2000 – Q3 2019, while the S&P averaged +5.6% per year, our top strategies averaged up to +54.1% per year.
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