CHMP Meeting Highlights October 2021

CHMP Monthly News | 03/11/2021

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

  • Active immunisation against Streptococcus pneumoniae
  • Atopic dermatitis
  • Non-small cell lung cancer
  • Paroxysmal nocturnal haemoglobinuria
  • Triple-negative breast cancer

New medicines recommended for approval:

Aspaveli (pegcetacoplan): is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months. PNH is a life-threatening blood disorder characterized by the destruction of red blood cells by the complement system. This occurs most commonly as a result to a somatic mutation that alters the exterior surface proteins of red blood cells, rendering these susceptible to be attacked by the complement. Aspaveli binds and inhibits the C3 subunit of the complement, thereby reducing haemolysis. For more information please consult the product page for Aspaveli on the EMA website.

Cibinqo (abrocitinib): is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are candidate for systemic therapy. AD is a chronic and complex disease, characterised by dry and pruritic skin. Although the aetiology is not fully understood, the main contributors seem to be an altered permeability of the skin due to perturbations in the epidermal barrier and an inappropriate immune response, which results in skin inflammation and contributes to the epidermal barrier disruption. Cibinqo selectively inhibits Janus kinase 1 (JAK1), thereby disrupting the cytokine signalling cascade involved in AD. For more information please consult the product page for Cibinqo on the EMA website.

Rybrevant (amivantamab): received a positive opinion for a conditional marketing authorisation (CMA). It is indicated as monotherapy for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy. NSCLC is a serious and often fatal disease, that accounts for over 85% of all lung cancers. Although mutations in the EGFR proto-oncogene are common in this setting, only about 10% are insertions in exon 20. Approved tyrosine kinase inhibitors (TKIs) cannot bind and inhibit the resulting aberrant proteins, rendering the arising tumours resistant to these TKIs. Rybrevant is a bispecific antibody targeted against EGFR and MET, although the mechanism by which it inhibits tumours is not fully understood. For more information please consult the product page for Rybrevant on the EMA website.

Trodelvy (sacituzumab govitecan): is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. TNBC accounts for around 15% of all invasive breast cancers and it is associated with poor prognosis. These tumours are characterised by a lack of human epidermal growth factor 2 (HER2), oestrogen and progesterone receptor expression, which renders them insensitive to hormonal therapy or HER2-targeted medicines. Trodelvy is a first-in-class antibody-drug conjugate which includes a monoclonal antibody targeted against trophoblast cell surface antigen 2 (Trop-2), covalently bound to the topoisomerase I inhibitor SN-38 through a hydrolysable linker. Since overexpression of Trop-2 is common in malignant tumours, Trodelvy is recruited to the tumour through its antibody component. The SN-38 component is then released, intra- and extracellularly, upon hydrolysis of the linker. For more information please consult the product page for Trodelvy on the EMA website.

Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)): is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. Invasive disease and pneumonia caused by an infection with S. pneumoniae result in high morbidity and mortality, especially in the elderly and in patients with comorbidities or immunocompromised.Vaxneuvance is a conjugate vaccine that contains pneumococcal polysaccharides from 15 serotypes, conjugated to a carrier protein from Corynebacterium diphtheriae. For more information please consult the product page for Vaxneuvance on the EMA website.

Recommendations on extensions of therapeutic indication:

Edistride (dapagliflozin): extension of indication to include the treatment of children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance.
  • in addition to other medicinal products for the treatment of type 2 diabetes.

For more information please consult the product for Edistride on the EMA website.

Forxiga (dapagliflozin): extension of indication to include the treatment of children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance.
  • in addition to other medicinal products for the treatment of type 2 diabetes.

For more information please consult the product for Forxiga on the EMA website.

Hizentra (human normal immunoglobulin (SCIg)): The indication has been updated. Hizentra is now indicated as replacement therapy for the treatment of secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of < 4 g/l. Hizentra is also approved as replacement therapy for primary immunodeficiency syndromes and as immunomodulatory therapy for chronic inflammatory demyelinating polyneuropathy. For more information please consult the product for Hizentra on the EMA website.

Keytruda (pembrolizumab): extension of indication to include, in combination with lenvatinib, the first‑line treatment of advanced renal cell carcinoma in adults. Keytruda is also authorised, in combination or as monotherapy, for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer and oesophageal carcinoma. For more information please consult the product for Keytruda on the EMA website.

Keytruda (pembrolizumab): extension of indication to include, in combination with lenvatinib, the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation. For more information please consult the product for Keytruda on the EMA website.

Kisplyx (lenvatinib): extension of indication to include, in combination with pembrolizumab, the first‑line treatment of adults with advanced renal cell carcinoma. For more information please consult the product for Kisplyx on the EMA website.

Lenvima (lenvatinib): extension of indication to include, in combination with pembrolizumab, the treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation. Lenvima is also indicated as monotherapy for the treatment of differentiated thyroid carcinoma and hepatocellular carcinoma. For more information please consult the product for Lenvima on the EMA website.

Repatha (evolocumab): extension of indication to include the treatment of paediatric patients aged 10 years and over with homozygous or heterozygous familial hypercholesterolaemia. Repatha alone or in combination is also indicated for the treatment of established atherosclerotic cardiovascular disease and mixed dyslipidaemia. For more information please consult the product for Repatha on the EMA website.

Skyrizi (risankizumab): extension of indication to include, alone or in combination with methotrexate, the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. Skyrizi had previously also been approved for the treatment of plaque psoriasis. For more information please consult the product for Skyrizi on the EMA website.

Xeljanz (tofacitinib): extension of indication to include the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Xeljanz is also indicated for the treatment of rheumatoid and psoriatic arthritis, ulcerative colitis and juvenile idiopathic arthritis. For more information please consult the product for Xeljanz on the EMA website.

Zeposia (ozanimod): extension of indication to include the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia had previously been authorised for the treatment of multiple sclerosis. For more information please consult the product for Zeposia on the EMA website.

Newly published EPARs:

The EPAR (European public assessment report) is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available at the EMA homepage between 11-14 October 2021:

Koselugo (selumetinib): for the treatment of plexiform neurofibromas, EPAR Koselugo.

Ozawade (pitolisant): to improve wakefulness and reduce excessive daytime sleepiness in adult patients with obstructive sleep apnoea. EPAR Ozawade.

Recently started procedures:

Every month, new medicines are submitted to the EMA for approval to provide patients with new treatment options for various diseases. The CHMP conducts a scientific assessment of the applications and makes a recommendation. The CHMP has started the evaluation of the following submitted applications:

  • Asciminib - Orphan - Treatment of Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase.
  • Egartigimod alfa - Orphan - Treatment of generalised Myasthenia Gravis.
  • Lenacapavir - Treatment of human immunodeficiency virus type 1 (HIV-1) infection.
  • Mitapivat - Orphan - Treatment of pyruvate kinase deficiency.
  • Mobocertinib - Treatment of adult patients with epidermal growth factor receptor exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer.
  • Octreotide - Orphan - Treatment of acromegaly.
  • Surufatinib - Treatment of progressive neuroendocrine tumours.
  • Tebentafusp - Orphan - Treatment of uveal melanoma.
  • Valoctocogene roxaparvovec - Orphan, Advanced therapy medicinal product (ATMP) - Treatment of severe haemophilia A.
  • Voclosporin - Indicated in combination with background immunosuppressive therapies for the treatment of adult patients with class III, IV or V (including mixed class III/V and IV/V) lupus nephritis.

Other topics of interest:

Re-election of Bruno Sepodes as CHMP vice-chair

The CHMP re-elected Bruno Sepodes as its vice-chair for a second three-year term, starting in October 2021.

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