WC500185968

Procedure scope: Proposal for a new and alternative study BV29684 ‘assessing the safety of prenatal
exposure to oseltamivir’ as category 3 study (MEA 099) to replace the agreed 2-year extension of the
Danish-Swedish registry (NV25577)
MAH(s): Roche Registration Ltd
Background
For background information, see PRAC Minutes January 2015.
Further information as requested by the PRAC was received and assessed by the PRAC Rapporteur.
Summary of advice
The RMP version 12 for Tamiflu (oseltamivir), replacing the two year-extension of study
NV25577 (2-year extension of the Danish-Swedish registry assessing the safety of oseltamivir
exposure in pregnant women in Denmark and Sweden) with the proposed new study BV 29684
(assessing the safety of prenatal exposure to oseltamivir), was not considered acceptable as it
was not a suitable replacement for the requested extension of study NV 25577. The MAH
should provide further justification for not performing study NV25577. In addition, the MAH
should address the remaining PRAC questions and further justify how the new proposed study
BV 29684 overcomes the limitations previously raised and how it better addresses the scientific
question investigated. A request for further information to be addressed by the MAH was
agreed before the procedure is concluded.
RMP in the context of a variation – CHMP-led procedure
5.2.2. Crizotinib – XALKORI (CAP)
Evaluation of an RMP in the context of a variation, extension of indication
Regulatory details:
PRAC Rapporteur: Arnaud Batz (FR)
Administrative details:
Procedure number(s): EMEA/H/C/002489/II/0024
Procedure scope: Extension of indication to the first-line treatment anaplastic lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC) and to update SmPC sections 4.2, 4.4, 4.8, 5.1
and 5.2 to include results of the pivotal Study A8081014, a multinational, multicentre, randomized,
open-label, phase 3 study comparing the efficacy and safety of crizotinib to first-line chemotherapy
(pemetrexed/cisplatin or pemetrexed/carboplatin) in patients with previously untreated ALK-positive
advanced non-squamous NSCLC and updated safety results from studies A8081001, A8081005 and
A8081007. In addition, SmPC section 5.1 was revised to include updated overall survival data from
studies A8081001 and A8081005
MAH(s): Pfizer Limited
Background
Crizotinib is a protein kinase inhibitor indicated for the treatment of adults with previously treated
anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
The CHMP is evaluating an extension of the therapeutic indication for Xalkori, a centrally authorised
product containing crizotinib, to extend the indication to the first-line treatment of ALK-positive
advanced NSCLC. The PRAC is responsible for providing advice to the CHMP on the necessary updates
to the RMP to support this extension of indication.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 29/89