Convergence: Upfront planning, communication critical to ensuring success in real-time oncology reviews

Regulatory NewsRegulatory News | 13 September 2022 |  By 

Grace Gao (left) and James Cross (right)

PHOENIX, AZ – Developing an application through FDA’s real-time oncology review (RTOR) program is a labor-intensive process. Companies should have an “all-hands on deck mentality” as soon as clinical data becomes available and be prepared to answer questions from the US Food and Drug Administration (FDA) quickly, said panelists at a session on FDA oncology initiatives on a 13 September at RAPS Convergence 2022.
During the discussion, an industry expert said the benefits of submitting a product through the RTOR pathway can shave two months off the review time.
James Cross, vice president, regulatory affairs at Asher Biotherapeutics, said that going through the ROTR filing process “can get pretty complicated, but if you do a lot of work upfront, you will have a less challenging clinical development program.”
The pilot was announced in 2018 to facilitate earlier review of promising new cancer treatments; the program enables FDA to use “topline results and datasets, after datasets are locked, to support an earlier start to the application review.” (RELATED: FDA credits pilots for three-week review of new Kisqali indication, Regulatory Focus 20 July 2018)
FDA published its draft guidance on real-time oncology review in July 2022. (RELATED: FDA explains the ins and outs of real-time oncology review program in new guidance, Regulatory Focus 26 July 2022)
Tamy Kim, director of regulatory affairs and policy at FDA’s Oncology Center for Excellence, said the total number of approved applications submitted through the RTOR pathway increased from 18 new molecular entities (NMEs) and supplemental applications in 2020 to 30 in 2021.
About 27% of oncology applications are now submitted through the RTOR while 28% of supplemental applications are submitted through RTOR.
All hands on deck
Grace Gao, regulatory program manager at Roche, discussed the company’s experience with real-time oncology review. The company has submitted six applications through the RTOR pathway, including ones for Kadcyla (trastuzumab emtansine), Tecentriq (atezolizumab), Venclexta (venetoclax) and Gavreto (pralsetinib).
Gao said that once FDA accepts the products for the ROTR program, “It is all hands-on deck once you get the data.” It is important to have enough staff available and be ready to answer questions quickly from FDA, she said. Sponsors should also be aware that safety update reports may be requested sooner than the typical timelines and that different review divisions may have different preferences for how they expect to communicate with sponsors.
“We have to seek alignment on the expected level of communication, the type of method and the frequency,” Gao said, adding that some review divisions may want somewhat biweekly meetings while some may want communications offline or through emails.
Gao encouraged sponsors to use the assessment aid in their ROTR, which is a voluntary submission tool designed by OCE to increase review efficiency and consistency.
One of the benefits of the intense review process is that applications can undergo a quicker review, though the Prescription Drug User Fee Act (PDUFA) goal date is unchanged with RTOR.
“We did see two months earlier compared to PDUFA review time,” Gao said.
During a question-and-answer session, panelists were asked whether developing a quality target product profile (QTPP) for the drug helps expedite the submission process.
“The TPP is definitely something that we value, yet this has to come up organically. It takes time to develop a QTPP,” Cross said.
RAPS Convergence


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