Karyopharm Therapeutics Inc (NASDAQ:KPTI) stock fell Wednesday after a US Food and Drug Administration (FDA) advisory committee voted to wait for more data on cancer drug selinexor.
The Oncologic Drugs Advisory Committee (ODAC) reviewing Karyopharm’s selinexor for the treatment of patients with multiple myeloma voted 8 to 5 recommending the FDA wait for results from Karyopharm’s Phase 3 BOSTON study, before making a final decision regarding approval.
Karyopharm Therapeutics stock tumbled 14.8% to $4.16.
READ: Baird ‘more cautious’ on Karyopharm Therapeutics getting quick FDA approval for cancer drug selinexor
The BOSTON study is evaluating selinexor in combination with Velcade (bortezomib) and low-dose dexamethasone compared to bortezomib and low-dose dexamethasone in patients with multiple myeloma who have had one to three prior lines of therapy.
In the selinexor arm of the study, both selinexor and bortezomib are administered once per week, while in the control arm bortezomib is administered at its currently indicated, twice per week schedule.
Karyopharm said patient enrollment in the BOSTON study is now complete and topline data is expected by the end of 2019, or into 2020 and is linked to “progression-free survival events,” a primary endpoint in the trial.
“While we are disappointed with ODAC’s recommendation to delay the potential approval of selinexor, we plan to work with the FDA to evaluate the best path forward as they continue to review our NDA,” said Karyopharm Therapeutics CEO Sharon Shacham. “We are committed to working with the FDA, patients, and the myeloma community with the goal to provide selinexor as an option for those patients with no other options of known clinical benefit.”
Karyopharm’s new drug application (NDA) was earlier made based on Part 2 of the Phase 2b trial dubbed STORM. The FDA accepted the application on October 5, according it Priority Review status, cutting the review period to six months.
Although there are dampened expectations linked to speedy approval, analysts at Baird maintain an Outperform rating on Karyopharm Therapeutics shares.
Contact Uttara Choudhury at firstname.lastname@example.org