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Three more oncology indications
given accelerated approval are being withdrawn from the U.S. market at the
request of the FDA. Those mark just shy of 20 oncology indications and/or
drugs that have been approved through that accelerated pathway and then subsequently
retracted since 2020.
Roche and GSK drugs among
the latest withdrawals
- Most recently, Roche said
on Nov. 29 that it was voluntarily withdrawing Tecentriq’s
indication for the treatment of adults with locally advanced or
metastatic urothelial carcinoma who are not eligible for
cisplatin-containing chemotherapy and whose tumors express programmed
death-ligand 1 or are not eligible for any platinum-containing
chemotherapy regardless of PD-L1 status.
- The drug’s
Phase III IMvigor 130 trial, which was required for conversion of
accelerated approval to regular approval, did not meet the co-primary
endpoint of overall survival for Tecentriq plus chemotherapy compared
with chemotherapy alone, said the company. The withdrawn bladder cancer
indication is the last of the drug’s accelerated approvals that had not
been confirmed.
- Last year the
company withdrew
two other accelerated indications for the
immunotherapy.
- GSK plc also
pulled back two oncology indications recently. On Nov. 11, the
company revealed that it will limit the second-line
maintenance indication for Zejula in patients with recurrent epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in a
complete or partial response to platinum-based chemotherapy to those
patients who have deleterious or suspected deleterious germline BRCA
mutations.
- Then on Nov.
22, GSK said it would
withdraw its U.S. marketing authorization for Blenrep. The B-cell
maturation antigen (BCMA)-directed antibody and microtubule inhibitor
conjugate was approved for the treatment of adults with relapsed or
refractory multiple myeloma who have received at least four therapies
including an anti-CD38 monoclonal antibody, a proteasome inhibitor and
an immunomodulatory agent. That indication was the only one for
Blenrep.
Studies have prompted
scrutiny of pathway
- Numerous
studies over the past few years have brought increased scrutiny to the
accelerated approval pathway and its use with cancer agents. A study
published in August on JAMA Health Forum revealed that
of the oncology indications given accelerated approval between Jan. 1,
2007, and Dec. 31, 2021, only 36% were rated as having high added
therapeutic value compared with 53.3% for noncancer indications.
- A study
published in JAMA Oncology in June 2018,
meanwhile, found that of the 93 new accelerated approval hematology and
oncology indications from Dec. 11, 1992, to May 31, 2017, only slightly
more than half — 55% — had completed confirmatory trials in a median of
3.4 years after approval, while 40% had not completed those trials.
- And another
study published in BMJ in September 2021 showed that
even after a negative confirmatory trial, one-third of indications
remained on a cancer drug’s label, and half had the second highest level
of recommendation in National Comprehensive Cancer Network (NCCN)
guidelines.
- Various
industry experts have called for a variety of
overhauls to the pathway. Richard Pazdur, M.D., director of the
FDA's Oncology Center of Excellence, has said he’d like to require
manufacturers not only to communicate their confirmatory study plan
early in the approval process but also to have these trials underway
when they submit their applications for accelerated approval.
- “Accelerated
approval is aimed at the patients,” Pazdur
said during the 2022 Friends of Cancer Research annual
meeting. “It’s not an incentive program for the industry.”
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