Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022
News
Human
COVID-19
Medicines
Five new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2022 meeting.
The monoclonal antibody Evusheld (tixagevimab / cilgavimab) received a positive opinion from the CHMP for the prevention of COVID-19. More details are available in a separate news announcement.
A new gene therapy, Carvykti* (ciltacabtagene autoleucel), received a positive opinion for a conditional marketing authorisation for the treatment of multiple myeloma. Carvykti had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. See more details in the news announcement in the grid below.
Two medicines were submitted in hybrid applications, which means they relied in part on the results of pre-clinical tests and clinical trials of an already authorised reference product, and in part on new data: Camcevi (leuprorelin) for the treatment of hormone-dependent prostate cancer and Zolsketil pegylated liposomal (doxorubicin) for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.
A generic medicine, Amifampridine SERB (amifampridine), received a positive opinion from the Committee for the treatment of Lambert-Eaton myasthenic syndrome.
Recommendations on extensions of therapeutic indication for five medicines
The Committee recommended six extensions of indication for medicines that are already authorised in the European Union (EU): Cabometyx, Jakavi, Keytruda (for which there were two extensions), Kymriah* and Polivy*.
Withdrawals of application
The application for a marketing authorisation for Dimherity (dimethyl fumarate) was withdrawn. Dimherity was intended for the treatment of adult patients with relapsing remitting multiple sclerosis.
A question-and-answer document on the withdrawal is available in the grid below.
Other updates
Concluding a review of an application to extend the use of Vyxeos liposomal* (daunorubicin / cytarabine), the CHMP did not recommend including the treatment of young patients (aged 1 to 21 years) with acute myeloid leukaemia (AML) to the authorised indications. The Committee agreed that relevant data from the study submitted with the application should be included in the medicine’s product information so that healthcare professionals have access to up-to-date data on the effects of Vyxeos liposomal in patients with relapsing or refractory AML.
A question-and-answer document on the update is available in the grid below.
COVID-19 update
An increase in manufacturing capacity for COVID-19 vaccine Comirnaty was approved by the CHMP.
Agenda and minutes
The agenda of the March 2022 CHMP meeting is published on EMA's website. Minutes of the February 2022 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the March 2022 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Positive recommendations on new medicines
| Name of medicine | Carvykti |
| International non-proprietary name (INN) | ciltacabtagene autoleucel |
| Marketing-authorisation applicant | Janssen-Cilag International NV |
| Therapeutic indication | Treatment of multiple myeloma |
| More information |
News announcement: New gene therapy to treat adult patients with multiple myeloma |
| Name of medicine | Evusheld |
| INN | tixagevimab / cilgavimab |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Prevention of COVID-19 |
| More information |
News announcement: EMA recommends authorisation of COVID-19 medicine Evusheld |
Positive recommendations on new hybrid medicines
| Name of medicine | Camcevi |
| INN | leuprorelin |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of hormone-dependent prostate cancer |
| More information | Camcevi: Pending EC decision |
| Name of medicine | Zolsketil pegylated liposomal |
| INN | doxorubicin |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma |
| More information | Zolsketil pegylated liposomal: Pending EC decision |
Positive recommendations on new generic medicine
| Name of medicine | Amifampridine SERB |
| INN | amifampridine |
| Marketing-authorisation applicant | SERB SA |
| Therapeutic indication | Treatment of Lambert-Eaton myasthenic syndrome |
| More information | Amifampridine SERB: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Cabometyx |
| INN | cabozantinib |
| Marketing-authorisation holder | Ipsen Pharma |
| More information | Cabometyx: Pending EC decision |
| Name of medicine | Jakavi |
| INN | ruxolitinib |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | Jakavi: Pending EC decision |
| Name of medicine | Keytruda |
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information |
| Name of medicine | Kymriah |
| INN | tisagenlecleucel |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | Kymriah: Pending EC decision |
| Name of medicine | Polivy |
| INN | polatuzumab vedotin |
| Marketing-authorisation holder | Roche Registration GmbH |
| More information | Polivy: Pending EC decision |
| Name of medicine | Dimherity |
| INN | dimethyl fumarate |
| Marketing-authorisation holder | Sandoz GmbH |
| Therapeutic indication | Treatment of multiple sclerosis |
| More information | Dimherity: Questions and answers |