Another Eli Lilly oncology drug is in trouble, as Japan issues Verzenio safety warning
Eli Lilly is in trouble, again. This year, a late-stage failure prompted the withdrawal of its cancer drug Lartruvo; its erectile dysfunction treatment Cialis is being eaten up by generic competition; and in the first quarter, the US drugmaker relegated two mid-stage drugs to the scrap heap. Now, reports have emerged that Japan has flagged safety concerns associated with its breast cancer treatment, Verzenio.
Japan’s health ministry last week issued an alert that 14 patients taking the drug had developed a serious lung disease — of which at least four were suspected to have been caused by Verzenio, including one case of death, the Japan Times reported on Friday.
Verzenio was launched in Japan last November, and the oral drug has been administered in about 2,000 patients so far, the report said, citing the Health, Labor and Welfare Ministry.
Later on Wednesday, Lilly said it had updated Verzenio’s label in Japan to include a warning for interstitial lung disease (ILD)/pneumonitis following the report of several post-marketing cases. Previously, “ILD/pneumonitis was listed as an adverse reaction for Verzenio in the Japanese label when it was approved in September 2018, ” a company spokesperson told Endpoints News.
“ILD/pneumonitis is known to be more frequently observed in an East Asian population, and the majority of cases reported for Verzenio worldwide have been in Japan. The reason for higher incidence of noninfectious pneumonitis in this population is not fully understood, though differences in genetic sensitivity may play a role,” the spokesperson added.
After underwhelming in the fourth quarter, sales of Verzenio eclipsed expectations by $19 million in the first quarter of 2019 — a period in which overall revenue still came up short of Wall Street estimates — Cowen analysts wrote in a note last month.
Last year, Lilly’s newly crowned R&D chief Daniel Skovronsky touted Verzenio as one its top oncology prospects. The drug, originally approved by the FDA in 2017, competes with Novartis’ $NVS Kisqali and Pfizer’s $PFE Ibrance. It is now being primed for use in HR+/HER2- metastatic breast cancer, as well as for patients in the early stages of breast cancer.
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