GOTTLIEB OUTLINES PLANS TO MODERNIZE CANCER DRUG
Jun 3, 2018 4:17:00 GMT
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Post by stcks on Jun 3, 2018 4:17:00 GMT
GOTTLIEB OUTLINES PLANS TO MODERNIZE CANCER DRUG DEVELOPMENT, REVIEW
BY ERIN MCCALLISTER
At the American Society of Clinical Oncology (ASCO) meeting on Saturday, FDA Commissioner Scott Gottlieb highlighted steps the agency is taking to speed cancer drug development and review, including a pilot review program for supplemental efficacy applications, new guidance to relax enrollment criteria in trials and new standards for cell therapy manufacturing.
Gottlieb encouraged companies to rethink the traditional clinical trial construct, particularly in the academic setting, and to make trials more reflective of the real world and enrollment easier.
“It means enabling better access to experimental therapies being tested in clinical trials by modernizing eligibility criteria and conducting clinical trials in the communities where patients live. In my opinion, this transformation isn’t optional,” he said.
“In 2018, a patient’s hope for recovery shouldn’t hinge on socioeconomic status or a zip code lottery."
He encouraged industry to conduct pragmatic trials at the point of care: “This approach can help us systematically ask and answer critical clinical questions and design better patient matching strategies to optimize medical care, trial design, and product development."
Gottlieb said that FDA would be issuing guidance about how to include more under-represented patients in trials, including a guidance released on June 1 about the inclusion of adolescent patients in adult studies.
The guidance states that if there is no evidence that an investigational drug would have exaggerated toxicity in younger patients, sponsors should consider enrolling these individuals.
Gottlieb also announced two pilots the agency is launching to expedite the review of drug applications, starting with sBLAs and sNDAs.
The first, real-time oncology review (RTOR), would allow the safety and efficacy data to be reviewed earlier, before the complete application is filed. Once the database is locked, about two to four weeks later, the sponsor could submit a partial package of raw and derived data, including safety and efficacy, the study protocol, amendments and a draft of the package insert. After that, the agency would “immediately start evaluating the data for its sufficiency and integrity,” Gottlieb said.
The RTOR pilot will focus on supplemental efficacy applications.
The second pilot is a voluntary submission form template that sponsors can use to make the review process more efficient and consistent. Comments on the data by FDA and sponsors would be included in the same file, resulting in a single background document for processes, such as review by FDA’s Oncologic Drugs Advisory Committee (ODAC).
Gottlieb also said that FDA is working with NCI and other stakeholders to establish Good Manufacturing Processes (GMP) for cell and gene therapies that would allow manufacturers to use a general set of standards, helping facilities to scale up cell therapy manufacturing.
“Different treatments could share a common platform for manufacturing and delivering these therapies,” Gottlieb said.
BY ERIN MCCALLISTER
At the American Society of Clinical Oncology (ASCO) meeting on Saturday, FDA Commissioner Scott Gottlieb highlighted steps the agency is taking to speed cancer drug development and review, including a pilot review program for supplemental efficacy applications, new guidance to relax enrollment criteria in trials and new standards for cell therapy manufacturing.
Gottlieb encouraged companies to rethink the traditional clinical trial construct, particularly in the academic setting, and to make trials more reflective of the real world and enrollment easier.
“It means enabling better access to experimental therapies being tested in clinical trials by modernizing eligibility criteria and conducting clinical trials in the communities where patients live. In my opinion, this transformation isn’t optional,” he said.
“In 2018, a patient’s hope for recovery shouldn’t hinge on socioeconomic status or a zip code lottery."
He encouraged industry to conduct pragmatic trials at the point of care: “This approach can help us systematically ask and answer critical clinical questions and design better patient matching strategies to optimize medical care, trial design, and product development."
Gottlieb said that FDA would be issuing guidance about how to include more under-represented patients in trials, including a guidance released on June 1 about the inclusion of adolescent patients in adult studies.
The guidance states that if there is no evidence that an investigational drug would have exaggerated toxicity in younger patients, sponsors should consider enrolling these individuals.
Gottlieb also announced two pilots the agency is launching to expedite the review of drug applications, starting with sBLAs and sNDAs.
The first, real-time oncology review (RTOR), would allow the safety and efficacy data to be reviewed earlier, before the complete application is filed. Once the database is locked, about two to four weeks later, the sponsor could submit a partial package of raw and derived data, including safety and efficacy, the study protocol, amendments and a draft of the package insert. After that, the agency would “immediately start evaluating the data for its sufficiency and integrity,” Gottlieb said.
The RTOR pilot will focus on supplemental efficacy applications.
The second pilot is a voluntary submission form template that sponsors can use to make the review process more efficient and consistent. Comments on the data by FDA and sponsors would be included in the same file, resulting in a single background document for processes, such as review by FDA’s Oncologic Drugs Advisory Committee (ODAC).
Gottlieb also said that FDA is working with NCI and other stakeholders to establish Good Manufacturing Processes (GMP) for cell and gene therapies that would allow manufacturers to use a general set of standards, helping facilities to scale up cell therapy manufacturing.
“Different treatments could share a common platform for manufacturing and delivering these therapies,” Gottlieb said.