How to reform and accelerate approval of projects, many FDA experts emphasize a comprehensive strategy for global regulatory dynamics

Several FDA experts suggested that accelerating the reform of approved projects requires a comprehensive strategy

Several FDA experts suggested that accelerating the reform of approved projects requires a comprehensive strategy

Accelerated approval is a channel
established by the U.

Accelerated approval of this channel can accelerate drug
approval based on predicting alternative endpoints of clinical benefit, or intermediate clinical endpoints.

Reform of accelerated approval programs should not only focus on the post-grant process of granting accelerated approval, but also on factors such as clinical trial design, clinical endpoints, and patient population in studies that support accelerated approval and confirmation of clinical benefits prior to the granting of accelerated approval
.

Status of accelerated approvals

Status of accelerated approvals

Currently, accelerated approval is mainly used in the field of oncology, and in the past 10 years, anti-cancer therapies have accounted for 85%
of drugs that have received accelerated approval.

Anticancer therapies account for 85% of the drug clinical benefits of accelerated approved drugs 50% of the drug clinical benefit confirmed by subsequent clinical data 12% of the indications were withdrawn for 3.

One of the key factors in the length of time required is whether the drug developer has already initiated a confirmatory clinical trial
when it is approved for accelerated approval.

3.

Time required from obtaining accelerated approval to the next regulatory move (Image source: Reference [1])

Time required from obtaining accelerated approval to the next regulatory move (Image source: Reference [1])

FDA experts say that although these aspects have received more attention, but if you want to reform the accelerated approval program, you should also work on the drug developer to negotiate with the FDA to develop a plan to confirm clinical benefits before obtaining accelerated approval, reducing the time
required to confirm clinical benefits.

Considerations for alternative clinical endpoints

Considerations for alternative clinical endpoints

For example, in terms of clinical endpoints, the most common alternative endpoint used in the field of oncology to support accelerated approval is the durable overall response rate (ORR
).

ORR is a reliable marker of drug activity, however, the relationship between ORR and overall survival is uncertain in different cancer types and drug types

Clinical trial design considerations

Clinical trial design considerations

In terms of clinical trial design, FDA experts have commented that drug developers could consider directly initiating a randomized clinical trial to support both accelerated approval and subsequent validation of clinical benefits
.

Drug developers may consider initiating a randomized clinical trial directly to support both accelerated approval and subsequent validation of clinical benefits
.

Another strategy was to conduct two studies simultaneously: one one-arm study for accelerated approval based on overall response rate support, recruiting patients with limited treatment options; Another randomized study, as a confirmatory study, enrolled patients who
received fewer upfront treatments.

Another strategy was to conduct two studies simultaneously: one one-arm study for accelerated approval based on overall response rate support, recruiting patients with limited treatment options; Another randomized study, as a confirmatory study, enrolled patients who
received fewer upfront treatments.

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_msthash="345059" _msttexthash="12594309"> The European Medicines Agency plans to develop guidelines for the development and manufacture of synthetic peptides and synthetic oligonucleotides

The European Medicines Agency plans to develop guidelines for the development and manufacture of synthetic peptides and synthetic oligonucleotides

Recently, the European Medicines Agency (EMA) released a document saying that since the manufacturing process, analysis, characterization and quality standards of synthetic polypeptides and synthetic oligonucleotides still have a lot of content that has not been covered by existing guidelines, EMA plans to issue guidelines
for the development and manufacture of synthetic polypeptides and synthetic oligonucleotides.

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