The EC authorisation is supported by positive data from the Phase ½ FOENIX-CCA2 clinical trial, in which Lytgobi showed a 42% objective response rate (ORR), and a median duration of response (DOR) of 9.7 months
EC grants conditional authorisation for Taiho’s Lytgobi. (Credit: Steve Buissinne from Pixabay)
Japanese pharmaceutical company Taiho has received the European Commission (EC) conditional marketing authorisation for Lytgobi (futibatinib) to treat a type of bile duct cancer.
Lytgobi is indicated for adults with metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion, which progressed after at least one prior line of therapy.
EC grants conditional marketing authorisation for medicines that address an unmet medical need to treat serious diseases, whose benefits outweigh any risks associated with their usage.
CCA is an aggressive cancer of the bile ducts, which is associated with poor outcomes and needs new treatment options with its growing prevalence worldwide.
Under the specific obligations related to the conditional marketing authorisation, Taiho is required to provide additional clinical data on Lytgobi, until October 2027.
Taiho Oncology Europe medical affairs vice president Peter Foertig said: “Today is an important day for current and future patients with CCA as well as the healthcare providers who treat them.
“Lytgobi is an oral molecularly targeted medication that may provide clinically meaningful outcomes for patients undergoing treatment for CCA.”
Taiho Pharmaceutical managing director and Taiho Oncology Europe chairman Atsushi Azuma said: “Patients with CCA are often diagnosed at an advanced stage when surgery is not an option. We are pleased that Lytgobi now will be a new treatment option for patients with CCA.”
The EC authorisation is supported by data from the FOENIX-CCA2 clinical trial in 103 patients, conducted in France, Germany, Italy, the Netherlands, Spain, and the UK.
In the clinical trial, patients received once-daily Lytgobi oral tablets at a dose of 20mg until disease progression or unacceptable toxicity.
Patients treated with Lytgobi showed a 42% objective response rate (ORR) as assessed by independent review, which is the primary endpoint.
Also, the drug resulted in a median duration of response (DOR) of 9.7 months, which is a key secondary endpoint, and a total of 72% of the responses lasted more than 6 months.
Lytgobi may cause serious adverse reactions, including hyperphosphatemia, nail disorders, constipation, alopecia, diarrhoea, dry mouth, fatigue, nausea, dry skin, increased AST, abdominal pain, stomatitis, and vomiting, among others.
The drug is not recommended for pregnant women unless their clinical condition requires it.
FOENIX-CCA2 trial investigator John Bridgewater said: “FGFR2 fusions/rearrangements are one of the most frequent actionable alterations in CCA. As an irreversibly binding FGFR inhibitor, LYTGOBI targets FGFR in a unique way and offers new hope in a disease that, for me, has been among the most challenging to treat in my career.”
Last year, Taiho agreed to acquire Cullinan Pearl, a subsidiary of Cullinan Oncology, for up to $405m, and to partner with Cullinan to develop its lead candidate, CLN-081/TAS6417.