CHMP meeting highlights of 10-13 October 2022 - Oncology

Summary: On the 14th of October 2022, CHMP released its meeting highlights for the month of October. The main discussion points of the meeting are as follows: 

New Medicines Recommended for Approval 

Plerixafor Accord (plerixafor) - Accord Healthcare S.L.U. 

• Indication: treatment of lymphoma and multiple myeloma 

• Positive CHMP recommendation for the new generic medicine

Recommendations on Extensions of Therapeutic Indication 

Brukinsa (zanubrutinib) - BeiGene Ireland Ltd 

• Indication: treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy/monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). 
• Positive CHMP recommendation on extension of indications 

Withdrawals of Initial Applications 

Tuznue (trastuzumab) - Prestige Biopharma Belgium 

• Indication: treatment of certain forms of breast cancer and gastric (stomach) cancer. 
• The marketing authorisation application has been withdrawn by the applicant during the re-examination of the negative opinions that the committee adopted in May 2022.  

Hervelous (trastuzumab) - Prestige Biopharma Belgium 

• Indication: the treatment of early breast cancer and breast cancer that has spread to other parts of the body. 
• The marketing authorisation has been withdrawn by application by the applicant during the re-examination of the negative opinions that the committee adopted in May 2022.  

Unless accelerated, the European Commission can take up to 67 days to approve from the date of the CHMP opinion, thus approval of the above is likely mid-December 2022. 

Full text available here.