Merck & Co., Inc. (NYSE:MRK) Keytruda Reaches Blockbuster Status As European Application Withdrawn

Merck & Co., Inc. (NYSE:MRK) has announced that sales of its cancer immunotherapy, Keytruda, rose above $1 billion in the first time ever. At the same time the pharmaceutical giant withdrew an application it had submitted seeking for approval of the drug in Europe. With questions raised concerning future sales, shares of Merck fell dramatically as a result.

Though sales of Keytruda nearly tripled to reach a level of $1.05 billion, a cyber-attack that occurred in June crippled manufacturing temporarily. A decline in sales of products whose patents have expired also resulted in revenues in the third quarter falling by 2% to $10.33 billion.

Lung cancer market

According to Merck a third of the patients who had been newly diagnosed with lung cancer in the United States were starting treatment with Keytruda. Additionally the launch of the use of the immunotherapy for cases of bladder cancer was also progressing well. Currently in the oncology market lung cancer is the most lucrative by huge margins.

Per Seamus Fernandez, an analyst at Leerink Partners, almost all the current uses of Keytruda is in lung cancer despite the fact that the drug has been approved for the treatment of numerous types of cancers.

“Keytruda is almost completely reliant on the performance in first-line lung cancer,” said Fernandez.

Nonsquamous non-small cell lung cancer

Merck’s withdrawn European application was for the use of its Keytruda cancer drug as a therapy for NSCLC – nonsquamous non-small cell lung cancer, together with chemotherapy. According to Tim Anderson, an analyst at Sanford Bernstein, approval for the drug in Europe had been expected in 2018.

Five months ago the Food and Drug Administration had given accelerated approval to the combination. This made Keytruda the first immunotherapy, as well as the only one, to get approval as a first-line lung cancer treatment.

Merck has now indicated that it aims to make the main goal of a lung cancer trial being conducted on Keytruda together with chemotherapy as overall survival. Results of that study will consequently be delayed to early 2019.

On Friday shares of Merck & Co Inc fell by 6.06% to close the day at $58.24.

An ad to help with our costs