CHMP Meeting Highlights April 2022

CHMP Monthly News | 18/05/2022

This month, medicinal products for the following indications have received a positive opinion:

Epidermolysis bullosa
Follicular lymphoma
Non-small cell lung cancer
Uterine fibroids

New medicines recommended for approval:

Filsuvez (birch bark extract): for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older. EB is a heterogeneous group of rare genetic skin fragility conditions, which are characterised by easy blistering and erosions of the skin and mucosa. The different subtypes are classified into four main categories based on the level of skin cleavage: simplex, junctional, dystrophic and Kindler EB. EB is caused by a mutation in at least one of 16 genes encoding proteins involved in cellular adhesion and integrity. Filsuvez is a non-aqueous gel indicated for topical application, which promotes wound healing and closure. Although the mechanism of action is not clearly known, the product has shown anti-inflammatory effects. For more information please consult the product for Filsuvez on the EMA website.

Lunsumio (mosunetuzumab): received a positive opinion for a conditional marketing authorisation (CMA) as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the second most common non-Hodgkin lymphoma. Despite available therapies, FL remains an incurable disease. As many mature B-cell lymphomas, FL express the surface antigen CD20. Lunsumio is a first-in-class bispecific antibody that targets CD20 and CD3, a subunit of the T-cell receptor complex. Lunsumio binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with CD20, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis. For more information please consult the product for Lunsumio on the EMA website.

Tabrecta (capmatinib): as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. NSCLC accounts for over 85% of all lung cancers. MET is a proto-oncogene that encodes a tyrosine kinase receptor, also known as hepatocyte growth factor receptor (HGFR). Deletion or skipping of exon 14 in the MET gene increases the stability of the enzyme and renders it constitutively active. Tabrecta hinders MET downstream signalling by inhibiting its activation by phosphorylation. For more information please consult the product for Tabrecta on the EMA website.

Yselty (linzagolix choline): for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. CHMP re-adopted its positive opinion from December 2021 after further safety information emerged during the decision-making process.

Uterine fibroids are benign hormone-sensitive tumours of the uterus. The most troublesome symptoms are heavy menstrual bleeding and pain. Yselty is an antagonist of the gonadotropin-releasing hormone (GnRH) that, unlike other GnRH antagonist, can be taken orally. GnRH antagonists suppress the release of the luteinizing hormone and the follicle-stimulating hormone, which translates into a reduction in oestradiol levels. For more information please consult the product for Yselty on the EMA website.

Recommendations on extensions of therapeutic indication:

Bydureon (exenatide): extension of indication to include the treatment of adolescents and children aged 10 years and above with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control. For more information please consult the product for Bydureon on the EMA website.

Elonva (corifollitropin alfa): extension of indication to include the treatment, in combination with human Chorionic Gonadotropin, of adolescent males (14 years and older) with hypogonadotropic hypogonadism. Elonva was previously authorised for the Controlled Ovarian Stimulation in women participating in an Assisted Reproductive Technology program. For more information please consult the product for Elonva on the EMA website.

Keytruda (pembrolizumab): extension of indication for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence, as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, in combination with chemotherapy.

Keytruda had previously been authorised for the treatment of melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, triple-negative breast cancer, endometrial carcinoma, cervical cancer, gastric cancer, small intestine cancer and biliary cancer. For more information please consult the product for Keytruda on the EMA website.

NovoSeven [eptacog alfa (activated)]: extension of indication to include the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis. NovoSeven had previously been authorised for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures who suffer certain coagulopathies. For more information please consult the product for NovoSeven on the EMA website.

Retsevmo (selpercatinib): extension of indication for Retsevmo as monotherapy, to include the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Retsevmo had previously been authorised for the treatment of thyroid cancer and NSCLC following prior treatment with immunotherapy and/or platinum-based chemotherapy. For more information please consult the product for Retsevmo on the EMA website.

Tecentriq (atezolizumab): extension of indication for Tecentriq as monotherapy, to include the adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells and who do not have EGFR mutant or ALK-positive NSCLC. Tecentriq had previously been authorised for the treatment of urothelial carcinoma, NSCLC, small cell lung cancer, triple-negative breast cancer and hepatocellular carcinoma. For more information please consult the product for Tecentriq on the EMA website.

Yescarta (axicabtagene ciloleucel): extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma after three or more lines of systemic therapy. Yescarta had previously been authorised for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma. For more information please consult the product for Yescarta on the EMA website.

Newly published EPARs:

The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:

Breyanzi (lisocabtagene maraleucel): is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, after two or more lines of systemic therapy. EPAR Breyanzi.

Kimmtrak (tebentafusp): is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. EPAR Kimmtrak.