Other safety alerts
|
| |
| European Union: EMA confirms recommendation for non-renewal of authorisation of multiple myeolma medicine Blenrep |
| |
European Medicines Agency (EMA) announces that its human medicines committee (CHMP) has confirmed its initial recommendation to not renew the conditional marketing authorisation for Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.
Blenrep is a medicine for treating multiple myeloma (a cancer of the bone marrow). It was authorised for adults who had received at least four previous treatments and whose disease did not respond to certain other types of treatment and had worsened since the last treatment. During a re-examination requested by the company that markets the medicine, the CHMP re-assessed the results from the DREAMM-3 study, which compared Blenrep with pomalidomide plus low-dose dexamethasone.
The study did not find that patients who received Blenrep lived longer without their disease getting worse when compared with patients who received pomalidomide plus dexamethasone. As confirming this progression-free survival was a requirement at the time of Blenrep’s initial authorisation, the Committee concluded that the data did not confirm the medicine’s benefits and recommended not renewing its authorisation.
During the re-examination, the CHMP consulted a scientific advisory group (SAG) comprising of experts in the treatment of cancer. These experts were of the view that the DREAMM-3 study did not confirm the effectiveness of Blenrep. However, the majority of SAG experts were also of the opinion that Blenrep could be a treatment option for some patients for whom other treatments were not suitable.
In reaching its final opinion, the CHMP considered the views of the SAG, the results of the DREAMM-3 study which failed to confirm the effectiveness of Blenrep, and the medicine’s safety profile. All these considerations informed the CHMP’s conclusion that the benefits of Blenrep no longer outweigh its risks and its recommendation not to renew the medicine’s conditional marketing authorisation.
Information for patients:
- EMA has recommended not renewing the marketing authorisation for the cancer medicine Blenrep. Once this recommendation is confirmed by the European Commission, Blenrep will no longer be authorised in the EU. However, the company may still supply the medicine through compassionate use or named-patient programmes to patients already receiving Blenrep.
- Blenrep was approved to treat multiple myeloma. As data were limited at the time of authorisation, the medicine was approved on the condition that the company carried out a study to confirm its effectiveness.
- The DREAMM-3 study failed to show that patients treated with Blenrep lived longer without their disease getting worse compared with those treated with pomalidomide and low-dose dexamethasone, another authorised treatment for multiple myeloma.
- As the medicine's effectiveness could not be confirmed, EMA concluded that the benefits of Blenrep are considered to no longer outweigh its risks.
- If you are receiving Blenrep, you should speak to your doctor about this decision and what it means for you and your treatment.
Information for healthcare professionals:
- EMA has recommended not to renew the conditional marketing authorisation for Blenrep, because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.
- Once this recommendation is confirmed by the European Commission, Blenrep will no longer be authorised in the EU. However, the company may still supply the medicine through compassionate use or named-patient programmes to existing patients.
- Healthcare professionals should not start any new patients on Blenrep.
- Blenrep received a conditional marketing authorisation in August 2020; the marketing authorisation was subject to annual renewals based on the results of additional studies imposed on the marketing authorisation holder.
- The recent DREAMM-3 study failed to show that patients treated with Blenrep lived longer without disease progression than those treated with pomalidomide and low-dose dexamethasone.
- This phase 3, open-label, randomised (2:1) study compared Blenrep with pomalidomide and low-dose dexamethasone in 325 patients with relapsed/refractory multiple myeloma. The primary endpoint agreed as part of the specific obligation was superiority in investigator-assessed progression-free survival (PFS). The study found no statistically significant difference in PFS between the two groups (HR 1.03; 95% confidence interval: 0.72, 1.47).
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-confirms-recommendation-non-renewal-authorisation-multiple-myeloma-medicine-blenrep
In Hong Kong, there is one registered pharmaceutical product containing belantamab mafodotin, namely Blenrep Powder For Concentrate For Solution For Infusion 100mg (HK-67213) registered by GlaxoSmithKline Limited, and is a prescription-only medicine. Related news on non-renewal of authorization of multiple myeloma medicine Blenrep was previously issued by EMA, and was posted on Drug Office website on 16 Sep 2023. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 18 Sep 2023. In Sep 2023, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided to keep vigilant on any update from EMA and any change in worldwide marketing authorization.
In light of the above EMA’s announcement, the matter will be further discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, December 16, 2023
Issued at HKT 19:00
|
| |
|
