Merck's (MRK) Keytruda sBLA Accepted by FDA for Gastric Cancer
Merck MRK announced that the FDA accepted to review a new supplemental Biologics License Application (sBLA) for the blockbuster immunooncology drug Keytruda.
The sBLA is seeking approval for Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The regulatory body has set a target action date of Dec 16, 2023. The sBLA is based on positive data from the KEYNOTE-859 trial. Data from the study showed that Keytruda, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival (OS) versus chemotherapy alone, regardless of PD-L1 expression, in patients who were human epidermal growth factor receptor 2 (HER2) negative.
The anti-PD-1 therapy, Keytruda is currently approved in combination with Herceptin, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced, unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in the United States.
The FDA approved this indication under accelerated approval based on tumor response rate and durability of response data from the late-stage KEYNOTE-811 study and continued approval is contingent upon verification and description of clinical benefits in the confirmatory trials.
We remind investors that Merck is evaluating Keytruda in gastrointestinal cancers in multiple studies, which include KEYNOTE-811 in first-line advanced HER2-positive gastric cancer, KEYNOTE-585 in early-stage gastric cancer and LEAP-015 study in advanced/metastatic gastric cancer.
Concurrently, Keytruda is also being evaluated for multiple uses in hepatobiliary, esophageal, pancreatic, colorectal and biliary tract cancers.
Sales of the drug came in at $20.9 billion, up 27% year over year.
Shares of Merck have increased 3.9% in the year so far compared with the industry’s 2.8% rise.
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The phenomenal growth trajectory of Keytruda has propelled Merck’s growth story as well in the past few years and additional label expansion of the drug will further boost sales.
Keytruda’s sales are gaining from strong momentum in metastatic indications, including in some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, TNBC and MSI-H cancers and from rapid uptake across recent earlier-stage launches.
However, the company is heavily dependent on Keytruda for growth.
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some well-placed stocks in the overall healthcare sector are Novo Nordisk NVO and Ligand Therapeutics LGND, both carrying a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed the remaining three.
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