Is the accelerated approval process working for cancer immunotherapies?

By Samantha Black, PhD, ScienceBoard editor in chief
November 15, 2021

WASHINGTON, DC - Leveraging years of experience, Dr. Alessandra Cesano, PhD, who serves on the board of directors of the Society for Immunotherapy of Cancer (SITC), chaired a panel discussion on the accelerated approval process for cancer immunotherapies at the organization’s 2021 annual meeting. Cesano spoke with ScienceBoard at the meeting.

Cesano explained that the challenge with using the accelerated approval process for immunotherapies is that there is often amazing activity for a subset of patients but no response in other patient subsets. Since confirmatory studies for these immunotherapies often cannot provide sufficient data, the question therefore is whether these drugs that have been accelerated for approval should remained approved, or should they be taken off the market? In addition, does the accelerated process work for immunotherapy drugs?

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“The problem cannot be solved by science alone; you need all the stakeholders and data,” Cesano said. “Science is where everything starts, but the patient is where everything ends. To translate the science to the patient is a process that requires different competencies and different people, where everyone has a position at the table.”

Cesano further explained that she thinks that the industry does not lack science but rather the ability to translate science to patients. There is a disconnect between the number of therapies under investigation and the number of treatments that reach patients.

The COVID-19 pandemic showed that when the industry comes together, it has the technology and will to work together in a competitive environment to produce real solutions, Cesano said.

Cesano said she is looking forward to innovations quickly advancing beyond the science and reaching patients. She noted the importance of sharing data in precompetitive settings as a means to move faster on the transfer of information and knowledge so that patients can benefit.

Cesano is also on the faculty of SITC’s Women in Cancer Immunotherapy Leadership Institute. The institute provides mentorship for the next generation of female scientists by equipping them with the leadership tools they need to succeed. Ahead of the SITC's annual meeting each year, women from various disciplines meet to discuss important topics such as work-life balance.

"Seeing the new generation come in with their ideas and passions -- to be able to help them and build them up to be successful is great,” Cesano said.

Dr. Alessandra Cesano is also chief medical officer at ESSA Pharmaceuticals.

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Last Updated 7/21/2022 9:00:56 AM