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Lilly's (LLY) Erbitux Gets FDA Nod for Expanded Use in CRC
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Eli Lilly (LLY - Free Report) announced that the FDA has approved the expanded use of its drug Erbitux to treat colorectal cancer (“CRC”). The approval is for a combination of Erbitux (cetuximab) and Pfizer’s (PFE - Free Report) Braftovi (encorafenib) to treat adult patients with metastatic CRC with a BRAF V600E mutation who have already received prior therapy.
We remind investors that Pfizer’s Braftovi received approval from the FDA for the same indication in April 2020 in combination with Erbiux.
The FDA approval for Erbitux+ Braftovifor metastatic CRC with a BRAF V600E mutationindication was based on data from Pfizer’s phase III BEACON CRC study, which compared the Erbitux-Braftovi combo to irinotecan with Erbitux or Folfiri with Erbitux (the control arm) in previously treated patients with metastatic CRC with a BRAF V600E mutation.
Data from the study demonstrated that the Erbitux-Braftovi combo significantly improved overall survival in patients by 8.4 months compared to 5.4 months for the control arm. The Erbitux-Braftovi combo also achieved an objective response rate of 20% compared to 2% for the control arm. While the median progression-free survival (PFS) was 4.2 months in the Erbitux-Braftovi arm, the median PFS was 1.5 months in the control arm.
Lilly’s shares have rallied 31.3% so far this year in comparison with the industry’s 7% growth.
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This approval marks the seventh FDA approval of Erbitux. The drug is already approved for the treatment of several types of CRC, and head and neck cancers either as monotherapy or in combination with other therapies.
CRC is one of the most common types of cancer and the second leading cause of cancer deaths. The company estimates 149,500 cases of colon or rectum cancer in 2021 in the United States alone. Further, the risk of mortality in CRC patients with the BRAF V600E mutation is at least twice that of other wild-type BRAF mutations. The FDA approval to Erbitux in this new indication is expected to further fuel sales growth for Lilly in the long run.
Erbitux is also being evaluated in combination with other therapies to treat different types of CRC. Last week, Mirati Therapeuticsannounced that a combination of its leading KRAS inhibitor adagrasib combined with Erbitux achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC. Mirati is also evaluating this combo in multiple studies as a potential treatment for second-line CRC.
In a separate press release, the company announced that it will lower the list price of non-branded insulins, including the Insulin Lispro injection, in the United States from Jan 1, 2022. Following the lowering of prices, the Insulin Lispro injection will be available at an additional 40% discount - $82.41 for individual vials and $159.12 for a pack of five pens. This move is aimed at reducing out-of-pocket expenses to expand the reach of insulin to people without insurance coverage or those who have not joined the company’s affordability programs. The new list prices will also be 70% less than Lilly's branded Humalog U-100 counterparts.
Novo Nordisk’s earnings per share estimates for 2021 have increased from $3.09 to $3.26 in the past 60 days. The same for 2022 has risen from $3.36 to $3.61 over the same period. The stock has rallied 36.6% in the year so far.
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Lilly's (LLY) Erbitux Gets FDA Nod for Expanded Use in CRC
Eli Lilly (LLY - Free Report) announced that the FDA has approved the expanded use of its drug Erbitux to treat colorectal cancer (“CRC”). The approval is for a combination of Erbitux (cetuximab) and Pfizer’s (PFE - Free Report) Braftovi (encorafenib) to treat adult patients with metastatic CRC with a BRAF V600E mutation who have already received prior therapy.
We remind investors that Pfizer’s Braftovi received approval from the FDA for the same indication in April 2020 in combination with Erbiux.
The FDA approval for Erbitux+ Braftovifor metastatic CRC with a BRAF V600E mutationindication was based on data from Pfizer’s phase III BEACON CRC study, which compared the Erbitux-Braftovi combo to irinotecan with Erbitux or Folfiri with Erbitux (the control arm) in previously treated patients with metastatic CRC with a BRAF V600E mutation.
Data from the study demonstrated that the Erbitux-Braftovi combo significantly improved overall survival in patients by 8.4 months compared to 5.4 months for the control arm. The Erbitux-Braftovi combo also achieved an objective response rate of 20% compared to 2% for the control arm. While the median progression-free survival (PFS) was 4.2 months in the Erbitux-Braftovi arm, the median PFS was 1.5 months in the control arm.
Lilly’s shares have rallied 31.3% so far this year in comparison with the industry’s 7% growth.
This approval marks the seventh FDA approval of Erbitux. The drug is already approved for the treatment of several types of CRC, and head and neck cancers either as monotherapy or in combination with other therapies.
CRC is one of the most common types of cancer and the second leading cause of cancer deaths. The company estimates 149,500 cases of colon or rectum cancer in 2021 in the United States alone. Further, the risk of mortality in CRC patients with the BRAF V600E mutation is at least twice that of other wild-type BRAF mutations. The FDA approval to Erbitux in this new indication is expected to further fuel sales growth for Lilly in the long run.
Erbitux is also being evaluated in combination with other therapies to treat different types of CRC. Last week, Mirati Therapeutics announced that a combination of its leading KRAS inhibitor adagrasib combined with Erbitux achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC. Mirati is also evaluating this combo in multiple studies as a potential treatment for second-line CRC.
In a separate press release, the company announced that it will lower the list price of non-branded insulins, including the Insulin Lispro injection, in the United States from Jan 1, 2022. Following the lowering of prices, the Insulin Lispro injection will be available at an additional 40% discount - $82.41 for individual vials and $159.12 for a pack of five pens. This move is aimed at reducing out-of-pocket expenses to expand the reach of insulin to people without insurance coverage or those who have not joined the company’s affordability programs. The new list prices will also be 70% less than Lilly's branded Humalog U-100 counterparts.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank & Stock to Consider
Lilly currently carries a Zacks Rank #3 (Hold). A better-ranked in the same sector is Novo Nordisk (NVO - Free Report) , which currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novo Nordisk’s earnings per share estimates for 2021 have increased from $3.09 to $3.26 in the past 60 days. The same for 2022 has risen from $3.36 to $3.61 over the same period. The stock has rallied 36.6% in the year so far.