Breast cancer treatments have evolved dramatically over the years, so Kyowa Kirin has decided to stop selling a decades-old drug in the U.S.
Starting Aug. 31, Kyowa Kirin will no longer distribute or fulfill orders for Fareston, or toremifene, presented in 60 mg tablets, in the U.S., the company said Friday. The last day for placing orders will be Aug. 29.
“The decision aligns with the company’s Vision for 2030 and its focus on the discovery, development and delivery of novel therapies for patients,” the company said in a statement.
Fareston is a hormone therapy that blocks estrogen receptors. Other drugs in the same selective estrogen receptor modulators (SERMs) class include tamoxifen, known under the brand names Nolvadex and Soltamox.
These old therapies have been around for decades and have largely been replaced by newer meds, including selective estrogen receptor degraders (SERDs) such as AstraZeneca’s Faslodex. Fareston was approved by the FDA in 1997 to treat postmenopausal women with estrogen receptor-positive breast cancer.
Kyowa Kirin has been selling Fareston in the U.S. through an agreement with Finish company Orion Corporation. The Japanese pharma has previously notified Orion and the FDA of its decision to discontinue Fareston.
Kyowa Kirin stopped promoting Fareston more than five years ago, and demand has since declined thanks to generics and other available treatments, a company spokesperson told Fierce Pharma.
“These conditions, along with the company’s forward-looking strategy focusing on novel medicines with life-changing value, informed our decision to stop distribution,” the spokesperson said.
In 2023, Kyowa Kirin recorded no revenue from Fareston after reporting 0.1 billion Japanese yen (around $700,000) for two consecutive years prior. The number was again zero in the first half of 2024.
Kyowa is shifting its focus on to novel antibody technologies and cell and gene therapies. As a result, the company recently unveiled a plan to significantly reduce its small molecule drug discovery research activities.
The Japanese pharma also recently restructured its Asia-Pacific business, selling its entire operations in the Chinese mainland, including its five established brands in the country, to local firm WinHealth Pharma for about $104 million. Rights to several established medicines in South Korea, Malaysia, Thailand, Hong Kong, Macau and Taiwan were also offloaded.
Editor's Note: The story has been updated with additional comments from a Kyowa Kirin spokesperson.