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Eli Lilly Lartruvo Gets FDA Approval for Soft Tissue Sarcoma
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Eli Lilly and Company (LLY - Free Report) announced that the FDA has granted accelerated approval to its pipeline candidate Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adult patients with advanced soft tissue sarcoma (STS), not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin.
This is the first FDA-approved front-line therapy to win the regulatory nod for STS in four decades. It is also first monoclonal antibody to be approved for STS. Note that Lartruvo received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication.
However, Lartruvo has only been approved under accelerated approval. It was based on data from the phase II JGDG study. Under this program, Eli Lilly has to provide results from an ongoing confirmatory phase III study, ANNOUNCE, which is fully enrolled, for continued approval.
JGDG is an open-label, randomized, active-controlled study that evaluated 133 STS patients. The study compared Lartruvo, in combination with doxorubicin chemotherapy, with doxorubicin alone. The study demonstrated encouraging results with median overall survival (OS) improving by 11.8 months in patients on the Lartruvo arm.
Median progression-free survival (PFS) in patients treated with Lartruvo and doxorubicin was 8.2 months, compared to 4.4 months for doxorubicin alone.
We remind investors that last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a conditional marketing authorization of olaratumab for the same indication.
According to the American Cancer Society, around 12,000 new cases of STS were diagnosed in 2015, resulting in nearly 5000 deaths in the U.S. alone. Hence, Lartruvo will be able to cater to significant unmet medical need worldwide.
Eli Lilly has been working on building its pipeline and has a wide range of compounds in different stages of development. Notable pipeline agents include baricitinib (rheumatoid arthritis), abemaciclib (metastatic breast cancer and NSCLC), galcanezumab (cluster headache and migraine prevention) and AZD3293 (Alzheimer’s disease). Cyramza, a fully human monoclonal antibody, is approved for second-line metastatic gastric cancer, second-line non-small cell lung cancer (NSCLC) and second-line metastatic colorectal cancer. Meanwhile, solanezumab is being evaluated in mild Alzheimer’s patients with top-line data expected around the year end.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.9% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 cents to $1.79 for 2017 over the last 60 days.
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Eli Lilly Lartruvo Gets FDA Approval for Soft Tissue Sarcoma
Eli Lilly and Company (LLY - Free Report) announced that the FDA has granted accelerated approval to its pipeline candidate Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adult patients with advanced soft tissue sarcoma (STS), not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin.
This is the first FDA-approved front-line therapy to win the regulatory nod for STS in four decades. It is also first monoclonal antibody to be approved for STS. Note that Lartruvo received Fast Track, Orphan Drug and Breakthrough Therapy designations from the FDA for this indication.
However, Lartruvo has only been approved under accelerated approval. It was based on data from the phase II JGDG study. Under this program, Eli Lilly has to provide results from an ongoing confirmatory phase III study, ANNOUNCE, which is fully enrolled, for continued approval.
JGDG is an open-label, randomized, active-controlled study that evaluated 133 STS patients. The study compared Lartruvo, in combination with doxorubicin chemotherapy, with doxorubicin alone. The study demonstrated encouraging results with median overall survival (OS) improving by 11.8 months in patients on the Lartruvo arm.
Median progression-free survival (PFS) in patients treated with Lartruvo and doxorubicin was 8.2 months, compared to 4.4 months for doxorubicin alone.
We remind investors that last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a conditional marketing authorization of olaratumab for the same indication.
According to the American Cancer Society, around 12,000 new cases of STS were diagnosed in 2015, resulting in nearly 5000 deaths in the U.S. alone. Hence, Lartruvo will be able to cater to significant unmet medical need worldwide.
Eli Lilly has been working on building its pipeline and has a wide range of compounds in different stages of development. Notable pipeline agents include baricitinib (rheumatoid arthritis), abemaciclib (metastatic breast cancer and NSCLC), galcanezumab (cluster headache and migraine prevention) and AZD3293 (Alzheimer’s disease). Cyramza, a fully human monoclonal antibody, is approved for second-line metastatic gastric cancer, second-line non-small cell lung cancer (NSCLC) and second-line metastatic colorectal cancer. Meanwhile, solanezumab is being evaluated in mild Alzheimer’s patients with top-line data expected around the year end.
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Zacks Rank & Key Picks
Eli Lilly currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN - Free Report) , Exelixis, Inc. (EXEL - Free Report) and Axovant Sciences Ltd. (AXON - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 100.9% year to date.
Axovant’s loss estimates have narrowed from $1.41 to $1.39 for 2016 and from $1.85 cents to $1.79 for 2017 over the last 60 days.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>