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Merck (MRK) Keytruda Gets EU Nod for Expanded Breast Cancer Use
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Merck (MRK - Free Report) announced that the European Commission has approved its blockbuster PD-L1 drug, Keytruda for expanded use in high-risk early-stage triple-negative breast cancer (TNBC)
The approval is for Keytruda plus chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage TNBC at a high risk of recurrence.
The approval was based on data from the pivotal KEYNOTE-522 study. In the study, neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda as monotherapy showed statistically significant improvement in event-free survival (EFS) versus neoadjuvant treatment alone. The Keytruda arm reduced the risk of EFS events by 37% versus the neoadjuvant chemotherapy arm. The median follow-up time for all patients was 37.8 months.
Merck’s stock has risen 23.5% this year so far compared with an increase of 5.1% for the industry.
Image Source: Zacks Investment Research
In breast cancer, Keytruda is already approved for first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC in Europe. The latest approval expands the drug’s eligible patient population to those suffering from earlier stages of this difficult-to-treat cancer. The approval makes Keytruda the first immunotherapy in Europe for treating high-risk early-stage TNBC. It is also the second indication for Keytruda in breast cancer in Europe.
Keytruda was approved for a similar indication in the United States in July last year.
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.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked biotech stocks are Sesen Bio , Alkermes (ALKS - Free Report) and BELLUS Health .
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.1% in the year-to-date period.
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 30 days. Shares of ALKS have risen 21.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for BELLUS Health’s 2022 loss per share has narrowed from 87 cents to 76 cents while that for 2023 has gone down from $1.11 per share to 98 cents per share in the past 30 days. Shares of BLU have risen 0.3% year to date.
BELLUS Health has delivered a four-quarter negative earnings surprise of 2.68%.
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Merck (MRK) Keytruda Gets EU Nod for Expanded Breast Cancer Use
Merck (MRK - Free Report) announced that the European Commission has approved its blockbuster PD-L1 drug, Keytruda for expanded use in high-risk early-stage triple-negative breast cancer (TNBC)
The approval is for Keytruda plus chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage TNBC at a high risk of recurrence.
The approval was based on data from the pivotal KEYNOTE-522 study. In the study, neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda as monotherapy showed statistically significant improvement in event-free survival (EFS) versus neoadjuvant treatment alone. The Keytruda arm reduced the risk of EFS events by 37% versus the neoadjuvant chemotherapy arm. The median follow-up time for all patients was 37.8 months.
Merck’s stock has risen 23.5% this year so far compared with an increase of 5.1% for the industry.
Image Source: Zacks Investment Research
In breast cancer, Keytruda is already approved for first-line treatment of certain patients with locally recurrent unresectable or metastatic TNBC in Europe. The latest approval expands the drug’s eligible patient population to those suffering from earlier stages of this difficult-to-treat cancer. The approval makes Keytruda the first immunotherapy in Europe for treating high-risk early-stage TNBC. It is also the second indication for Keytruda in breast cancer in Europe.
Keytruda was approved for a similar indication in the United States in July last year.
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.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked biotech stocks are Sesen Bio , Alkermes (ALKS - Free Report) and BELLUS Health .
While Sesen Bio sports a Zacks Rank #1 (Strong Buy), Alkermes and BELLUS Health have a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 36.1% in the year-to-date period.
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 30 days. Shares of ALKS have risen 21.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%.
The Zacks Consensus Estimate for BELLUS Health’s 2022 loss per share has narrowed from 87 cents to 76 cents while that for 2023 has gone down from $1.11 per share to 98 cents per share in the past 30 days. Shares of BLU have risen 0.3% year to date.
BELLUS Health has delivered a four-quarter negative earnings surprise of 2.68%.