New Delhi: Swiss healthcare company F Hoffmann-La Roche AG is seeking US approval for a new breast cancer pill, giredestrant, which it expects could generate up to $15 billion in revenue, according to a Bloomberg report. The drug has completed three phases of human trials, and the US Food and Drug Administration (FDA) is expected to decide on its approval by late November or early December.
Giredestrant is a once-daily pill designed to block and degrade estrogen receptors, which can fuel the growth of certain breast cancers. The FDA has granted the drug priority review, expediting the approval process.
Results from a global Phase III trial of the drug were published in the New England Journal of Medicine on 1 October. The study included 373 women and men with hormone receptor-positive, HER2-negative metastatic breast cancer whose disease had progressed or returned after treatment.
The findings showed that patients who took giredestrant after surgery had a lower risk of cancer recurrence than those who received standard hormone therapy. The drug was also better tolerated, with fewer patients discontinuing treatment because of adverse effects.
Giredestrant is designed to target breast cancer tumours that are hormone receptor-positive, meaning their growth is driven by hormones such as estrogen. It belongs to a class of drugs known as selective estrogen receptor degraders (SERDs), which includes fulvestrant and elacestrant, developed by AstraZeneca and Menarini Group, respectively.
A separate study found that giredestrant could also help control advanced breast cancer, prompting Roche to seek a further FDA approval. In patients whose cancer had spread and stopped responding to initial treatments, combining giredestrant with everolimus, a targeted drug, nearly doubled the time they lived without their tumours growing.
According to Bloomberg, the drug could mark Roche’s return to the forefront of breast cancer treatment more than two decades after the launch of Herceptin, its targeted therapy for HER2-positive breast cancer. Herceptin helped establish Roche as a leader in the field, but the company has since faced competition from other drugmakers, including AstraZeneca, which developed Enhertu to treat HER2-positive cancers.
While awaiting the FDA’s decision, Roche is projecting sales potential of up to $15 billion for giredestrant, according to Bloomberg. The company has said the drug is more tolerable than other SERDs, potentially improving patients’ quality of life.
(Edited by Prashant Dixit)