Failing to confirm clinical benefit, Gilead pulls 2 accelerated approval indications for cancer drug
Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.
“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.
Zydelig was also approved in 2014 to treat relapsed chronic lymphocytic leukemia in the US and will remain on the market for that indication. Lymphoma doctor John Leonard wrote on Twitter the drug will likely still remain available off-label for those two uses that Gilead is pulling.
But with just $150 million in worldwide sales in 2019 and 2020 combined, Zydelig has yet to near blockbuster status, and the drug’s list price has risen considerably over the years, from $7,200 per month in 2014, when it first won approval, to almost $11,000 per month in 2019.
Additionally, Zydelig has marketing authorization to treat CLL and FL in the EU, UK, Canada, Australia, New Zealand and Switzerland. None of these approvals are affected by these withdrawals, Gilead said.
Zydelig is a first-in-class inhibitor of PI3K delta, a protein that is overexpressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.
The decision by Gilead to pull these two indications comes as the FDA has sought to clean house around so-called “dangling” accelerated approvals, meaning they have yet to complete or failed their confirmatory trials.
Following an ODAC meeting last summer to review six dangling indications, three indications have since been pulled voluntarily by the companies, and one has gone on to a full approval. Others, like Secura Bio, have also recently pulled a dangling accelerated approval.