June 29, 2022

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FDA withdraws accelerated approval for Bristol-Myers Squibb PTCL indication for Romidepsin

FDA withdraws accelerated approval for Bristol-Myers Squibb PTCL indication for Romidepsin



FDA withdraws accelerated approval for Bristol-Myers Squibb PTCL indication for Romidepsin

On May 6, the U.S. FDA officially announced that it had withdrawn the approval of Bristol-Myers Squibb’s Istodax (Romidepsin) for peripheral T-cell lymphoma (PTCL) indications. At the same time, the FDA also revoked the application of Teva’s 505(b)(2) anticancer drug due to the failure of its confirmatory trial.

FDA withdraws accelerated approval for Bristol-Myers Squibb PTCL indication for Romidepsin

Despite the rejection of the accelerated application, Bristol-Myers Squibb’s Istodax is still approved to treat cutaneous T-cell lymphoma in patients who have received at least one systemic therapy.

It is worth noting that in August last year, Bristol-Myers Squibb announced that it had withdrawn Istodax from the US market for the treatment of peripheral T-cell lymphoma after missing the primary endpoint of progression-free survival in a confirmatory phase III clinical trial. indications.

Romidepsin is a histone deacetylase inhibitor (HDACi), an epigenetic therapy, belonging to the histone deacetylase inhibitor class of anticancer drugs, developed by Clegene (Celegene).

It was approved by the FDA in 2009 and 2011, respectively, for patients with cutaneous T-cell lymphoma and peripheral T-cell lymphoma who have received at least one systemic therapy.

Oncology drugs have been the mainstay of the FDA’s accelerated approval of drugs, while a large number of drug applications were eventually forced or voluntarily withdrawn due to failed trials.

In February 2021, the indication of AstraZeneca Imfinzi for the treatment of bladder cancer was withdrawn by the US FDA;

In March and July 2021, the indications of Merck Keytruda for the treatment of small cell lung cancer and gastric cancer were withdrawn by the US FDA;

In June 2021, the indication of Bristol-Myers Squibb’s Opdivo for the treatment of small cell lung cancer and liver cancer was withdrawn by the US FDA;

In March and August 2021, the indications of Roche Tecentriq for the treatment of bladder cancer and breast cancer were withdrawn by the US FDA;

In October 2021, the indication of Agenus’ balstilimab for the treatment of cervical cancer was withdrawn by the US FDA;

Earlier this year, two lymphoma indications for Gilead’s Zydelig were also withdrawn.

As to what led to this result, these drugs were initially approved by the FDA for accelerated approval, but the application was eventually rejected due to the failure of the confirmatory trial, and even the Alzheimer’s disease drug Aduhelm has been controversial since the day it was approved.

Accelerated approval is a method used by the US FDA to accelerate the listing of drugs that treat serious diseases and have significant advantages compared with existing drugs, allowing patients to receive treatment as soon as possible.

However, the U.S. health and pharmaceutical communities have now expressed strong doubts about the U.S. FDA’s accelerated approval process.

After accelerated approval, pharmaceutical companies still need to conduct clinical studies to confirm the expected clinical benefit.

If confirmatory trials do not show that the drug provides clinical benefit, the FDA removes the drug from the market.

The clinical validation experiments of some drugs after they are marketed have been slow, or proved to be ineffective.

In many cases, the FDA has taken a long time to make a drug withdrawal decision (it took ten years to withdraw the accelerated approval of Istodax), which eventually led to patients receiving ineffective treatment, and the payer It also caused huge financial losses.

A growing number of failures point to the need for the FDA to make more sweeping changes to the accelerated approval process, such as adding completion deadlines to confirmatory trials or changing the conditions under which a drug enters the accelerated approval process.

Reference::

Over 10 years later, FDA officially pulls a BMS accelerated approval, and a Teva copycat falls with it

FDA withdraws accelerated approval for Bristol-Myers Squibb PTCL indication for Romidepsin

(source:internet, reference only)


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