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Merck (MRK) Keytruda Gets Europe Nod for Expanded Melanoma Use
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Merck (MRK - Free Report) announced that European Commission has approved its blockbuster PD-L1 inhibitor, Keytruda, for expanded use in adjuvant early-stage melanoma.
The approval is for Keytruda, as monotherapy for the adjuvant treatment of adults and adolescent patients aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.
Apart from stage IIB or IIC melanoma, the EC approved a label expansion of Keytruda to include adolescent patients aged 12 years and older with advanced melanoma and stage III melanoma (as adjuvant treatment following complete resection). The drug is already approved for these advanced disease stages in adults in Europe.
Approvals for the aforementioned label expansions of Keytruda make the drug the first anti-PD-1 immunotherapy treatment option for adults and adolescents in Europe for treating melanoma across different stages of the diseases — stage IIB, IIC and III melanoma — following complete resection.
The approvals for stage IIB and IIC melanoma were based on data from the phase III KEYNOTE-716 study, which demonstrated the potential of Keytruda to help reduce the risk of recurrence, including as distant metastases, in the above-mentioned patient group.
Keytruda was approved for a similar indication in the United States in December last year.
Merck’s stock has risen 21.5% this year so far compared with an increase of 5.9% for the industry.
Image Source: Zacks Investment Research
Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $4.81 billion in the quarter, up 23% year over year.
Keytruda sales are gaining from continued uptake in lung cancer and increasing usage in other cancer indications. Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy can further boost sales. Keytruda is presently approved to treat five indications in earlier-stage cancers in the United States. In the United States, Merck expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time.
Novo Nordisk’s earnings per share have risen from $3.35 per share to $3.48 per share for 2022 and from $3.94 per share to $4.19 per share over the past 60 days.
Earnings of Novo Nordisk beat estimates in each of the last four quarters, the average surprise being 7.56%. The stock has risen 4% in the past three months.
The Zacks Consensus Estimate for Sesen Bio’s2022 loss has declined from 46 cents to 44 cents per share in the past 60 days. Shares of SESN have risen 18.7% in the past three months.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 60 days. Shares of ALKS have risen 8.2% in the past three months.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
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Merck (MRK) Keytruda Gets Europe Nod for Expanded Melanoma Use
Merck (MRK - Free Report) announced that European Commission has approved its blockbuster PD-L1 inhibitor, Keytruda, for expanded use in adjuvant early-stage melanoma.
The approval is for Keytruda, as monotherapy for the adjuvant treatment of adults and adolescent patients aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.
Apart from stage IIB or IIC melanoma, the EC approved a label expansion of Keytruda to include adolescent patients aged 12 years and older with advanced melanoma and stage III melanoma (as adjuvant treatment following complete resection). The drug is already approved for these advanced disease stages in adults in Europe.
Approvals for the aforementioned label expansions of Keytruda make the drug the first anti-PD-1 immunotherapy treatment option for adults and adolescents in Europe for treating melanoma across different stages of the diseases — stage IIB, IIC and III melanoma — following complete resection.
The approvals for stage IIB and IIC melanoma were based on data from the phase III KEYNOTE-716 study, which demonstrated the potential of Keytruda to help reduce the risk of recurrence, including as distant metastases, in the above-mentioned patient group.
Keytruda was approved for a similar indication in the United States in December last year.
Merck’s stock has risen 21.5% this year so far compared with an increase of 5.9% for the industry.
Image Source: Zacks Investment Research
Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $4.81 billion in the quarter, up 23% year over year.
Keytruda sales are gaining from continued uptake in lung cancer and increasing usage in other cancer indications. Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy can further boost sales. Keytruda is presently approved to treat five indications in earlier-stage cancers in the United States. In the United States, Merck expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time.
Merck currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked biotech stocks are Novo Nordisk (NVO - Free Report) , Sesen Bio and Alkermes (ALKS - Free Report) . While Alkermes sports a Zacks Rank of 1, Sesen Bio and Novo Nordisk have a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Novo Nordisk’s earnings per share have risen from $3.35 per share to $3.48 per share for 2022 and from $3.94 per share to $4.19 per share over the past 60 days.
Earnings of Novo Nordisk beat estimates in each of the last four quarters, the average surprise being 7.56%. The stock has risen 4% in the past three months.
The Zacks Consensus Estimate for Sesen Bio’s2022 loss has declined from 46 cents to 44 cents per share in the past 60 days. Shares of SESN have risen 18.7% in the past three months.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 60 days. Shares of ALKS have risen 8.2% in the past three months.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.