Tags

Type your tag names separated by a space and hit enter

A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
Br J Clin Pharmacol. 2013 Sep; 76(3):396-411.BJ

Abstract

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations.

Authors+Show Affiliations

Rashmi Shah Consultancy Ltd, Gerrards Cross, UK.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Review

Language

eng

PubMed ID

23362829

Citation

Shah, Rashmi R., et al. "A Fresh Perspective On Comparing the FDA and the CHMP/EMA: Approval of Antineoplastic Tyrosine Kinase Inhibitors." British Journal of Clinical Pharmacology, vol. 76, no. 3, 2013, pp. 396-411.
Shah RR, Roberts SA, Shah DR. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors. Br J Clin Pharmacol. 2013;76(3):396-411.
Shah, R. R., Roberts, S. A., & Shah, D. R. (2013). A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors. British Journal of Clinical Pharmacology, 76(3), 396-411. https://doi.org/10.1111/bcp.12085
Shah RR, Roberts SA, Shah DR. A Fresh Perspective On Comparing the FDA and the CHMP/EMA: Approval of Antineoplastic Tyrosine Kinase Inhibitors. Br J Clin Pharmacol. 2013;76(3):396-411. PubMed PMID: 23362829.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors. AU - Shah,Rashmi R, AU - Roberts,Samantha A, AU - Shah,Devron R, PY - 2012/12/19/received PY - 2013/01/21/accepted PY - 2013/2/1/entrez PY - 2013/2/1/pubmed PY - 2014/5/3/medline KW - EMA KW - FDA KW - accelerated approval KW - conditional approval KW - priority review KW - tyrosine kinase inhibitors SP - 396 EP - 411 JF - British journal of clinical pharmacology JO - Br J Clin Pharmacol VL - 76 IS - 3 N2 - We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each other, providing a fair basis for comparison. The FDA had granted priority review to 12 TKIs but the EMA/CHMP did not grant the equivalent accelerated assessment to any. The FDA granted accelerated approvals to six (38%) and CHMP granted (the equivalent) conditional approvals to four (29%) of these agents. On average, the review and approval times were 205.3 days in the US compared with 409.6 days in the European Union (EU). The active review times, however, were comparable (225.4 days in the EU and 205.3 days in the US). Since oncology drug development lasts about 7 years, the 20 days difference in review times between the two agencies is inconsequential. Clock stops during review and the time required to issue an approval had added the extra 184.2 days to review time in the EU. We suggest possible solutions to expedite the EU review and approval processes. However, post-marketing emergence of adverse efficacy and safety data on gefitinib and lapatinib, respectively, indicate potential risks of expedited approvals. We challenge the widely prevalent myth that early approval translates into early access or beneficial impact on public health. Both the agencies collaborate closely but conduct independent assessments and make decisions based on distinct legislation, procedures, precedents and societal expectations. SN - 1365-2125 UR - https://neuro.unboundmedicine.com/medline/citation/23362829/A_fresh_perspective_on_comparing_the_FDA_and_the_CHMP/EMA:_approval_of_antineoplastic_tyrosine_kinase_inhibitors_ L2 - https://doi.org/10.1111/bcp.12085 DB - PRIME DP - Unbound Medicine ER -