ADR that result in revision of patient information
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| European Union: EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep |
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European Medicines Agency (EMA) announces that its human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer of the bone marrow). Blenrep is given to adults who have received at least four previous treatments and whose disease does not respond to certain other types of cancer treatment, and whose cancer has worsened since receiving the last treatment.
This recommendation follows a review of available data by the CHMP as part of the renewal of Blenrep’s marketing authorisation. In its review, the CHMP considered that results from a new study (DREAMM-3) did not confirm the effectiveness of Blenrep as agreed when conditional marketing authorisation was granted.
Because Blenrep was meant to address an unmet medical need for a serious disease, it received a conditional marketing authorisation in August 2020. This type of authorisation allows a medicine to be authorised on the basis of less comprehensive (complete) data than are normally required, and when the benefits of having the medicine available earlier outweigh any risks associated with using it while waiting for further evidence. Medicines with a conditional marketing authorisation are subject to specific post-authorisation obligations (such as a new study) that aim to generate comprehensive data on these medicines.
At the time of the initial authorisation, no comparative data for Blenrep were available. As a specific obligation, the CHMP therefore requested the company marketing Blenrep to carry out a study to confirm the safety and effectiveness of the medicine by comparing it with pomalidomide plus low-dose dexamethasone, another authorised treatment for multiple myeloma that has come back and has not responded to treatment.
The study found that patients who received Blenrep did not live longer without their disease getting worse than those who received pomalidomide plus dexamethasone. As this was the measure of effectiveness requested as part of the specific obligation, the medicine’s effectiveness could not be confirmed in its authorised use. Therefore, the CHMP recommended not renewing the marketing authorisation in the EU.
In its review the CHMP also consulted patient representatives and experts in the treatment of cancer and took their views into consideration when reaching its opinion.
EMA will now send the CHMP’s opinion to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Information for patients:
- The marketing authorisation for Blenrep will not be renewed and the medicine will no longer be available in the EU.
- Blenrep was approved to treat a serious disease called 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 study failed to show that patients treated with Blenrep lived longer without their disease getting worse than those treated with pomalidomide and low-dose dexamethasone, another authorised treatment for multiple myeloma.
- As this was the measure of effectiveness requested at the time the medicine was granted conditional authorisation, the medicine's effectiveness could not be confirmed in its authorised use.
- If you are receiving Blenrep, you should speak to your doctor about possible treatment alternatives.
Information for healthcare professionals:
- Blenrep will no longer be available following non-renewal of its conditional marketing authorisation.
- Healthcare professionals should not start any new patients on Blenrep.
- For patients currently using Blenrep, healthcare professionals should explain to patients that the medicine is no longer available and discuss with them suitable treatment alternatives.
- 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 their disease getting worse 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-recommends-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. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Sep 16, 2023
Issued at HKT 13:15
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