Study: FDA Approves Oncology Drugs Faster than EMA

Regulatory authorities in the United States approve more new oncology drugs before their counterparts in Europe. But FDA approvals more often comes before the publication of pivotal study results, according to a recent analysis published in JAMA Network Open.

Investigators found that 95% of new oncology therapies were approved in the United States before receiving European market authorization, and they were approved with a shorter review time. One third of oncology drugs were approved by the FDA before registrational study publication, compared with less than one-in-10 for new European Medicines Agency (EMA) oncology approvals.

Mark P. Lythgoe, MBBS

“In this cross-sectional study, we found that new oncology therapies receive market authorization in the United States earlier than in Europe,” investigators, led by Mark P. Lythgoe, MBBS, wrote. Lythgoe is an academic clinical fellow in Medical Oncology and Pharmacist in the Department of Surgery and Cancer at the Imperial College London.

“The FDA has shorter review times than the EMA overall and across all oncology therapy subtypes. Pharmaceutical manufacturers continue to submit market authorization applications earlier to the FDA, despite longer review times at the EMA. However, earlier FDA approvals come with the consequence that one-third precede publication of registrational trial, compared with only approximately 10% preceding European approval,” they wrote.

Investigators compared authorization dates for new oncology therapies approved over the past decade. They found that in total, 89 new oncology therapies were approved both in the United States and Europe from 2010 to 2019. The FDA approved 85 oncology therapies (95%) before European authorization and four therapies (5%) after. But 35 oncology therapies (39%) were approved by the FDA prior to pivotal study publication, compared with eight (9%) by the EMA.

Investigators evaluated submission dates, review length, and approval relative to publication of the supporting clinical trials in a peer-reviewed journal. They identified new cancer therapies approved by both the FDA and EMA from Jan. 1, 2010, to Dec. 31, 2019.

The median delay in market authorization for new oncology therapies in Europe was 241 (150 to 370) days compared with the United States. The median review time was 200 (155 to 277) days for the FDA and 426 (358 to 480) days for the EMA. Sixty-four new licensing applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA.

Investigators said their analysis was limited to initial approvals and excluded supportive medicines, biosimilars, new formulations, and supportive and ancillary drugs. Additionally, they only official review times and did not take account of presubmission inquires or real-time oncology reviews used by both regulators as these are often confidential and information is frequently not in the public domain.