Activity

Activity ID

5702

Expires

June 14, 2021

Format Type

Journal-based CME

CME Credit

1

Fee

$30
CME Provider

JAMA Oncology

Description
Abstract

Importance:
Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or life-threatening.

Observations:
This review describes all malignant hematology and oncology AAs from inception of the program on December 11, 1992, to May 31, 2017. During this period, the FDA granted AA to 64 malignant hematology and oncology products for 93 new indications. Of these AAs, 53 were for new molecular entities. Overall, the end point of response rate, including hematologic response rates, accounted for most AAs (81 [87%]), followed by time-to-event end points of progression-free survival or time to progression (8 [9%]) and disease-free survival or recurrence-free survival (4 [4%]). Single-arm trial designs provided the data for 67 (72%) of the initial AA indications. Of the 93 AAs, 51 (55%) have fulfilled their postmarketing requirement and verified benefit in a median of 3.4 years after their initial AA. Thirty-seven (40%) indications have not yet completed confirmatory trial(s) or verified benefit, and 5 indications receiving AA (5%) have been withdrawn from the market.

Conclusions and Relevance:
The use of the AA program during the past 25 years has increased over time, and only a small portion of indications under the AA program fail to verify clinical benefit. For patients with serious or life-threatening oncologic diseases, AA brings products to the market years before confirmatory trials are typically completed.

Disclaimers
1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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More Information
Commercial Support?
No

NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

Educational Objectives

To learn the outcome of the US Food and Drug Administration Accelerated Approval program for Malignant Hematology Oncology Drugs and Biologics.

Keywords

Drug Development, Hematology, Law and Medicine, Oncology, Surgery

Competencies

Medical Knowledge

CME Credit Type

AMA PRA Category 1 Credit

Additional Information

doi:10.1001/jamaoncol.2017.5618

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