CHMP Meeting Highlights November 2024
This month, medicinal products for the following indications have received a positive opinion:
- Alzheimer’s disease
- SARS-CoV-2 induced acute repiratory distress syndrome (ARDS)
- Non-small cell lung cancer (NSCLC)
- Solid tumours
New medicines recommended for approval:
Augtyro (repotrectinib): has received a positive opinion for a conditional marketing authorisation for the treatment of adult patients with ROS1-positive advanced NSCLC.
Further has it received a positive opinion or the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and
- who have received a prior NTRK inhibitor, or
- have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted.
Non-small cell lung cancer (NSCLC) is a serious and often fatal disease that accounts for 80 to 85% of all lung cancers. A significant number of patients present with driver mutations in oncogenes, some of which can be aimed at by targeted therapies. Patients without known driver mutations need broader-acting therapies.
Repotrectinib is a tyrosine kinase inhibitor that binds to different kinases including ROS1 and TrkA, B and C. ROS1 is a protooncogen and an inhibition of it slows the cell proliferation of the tumour. For more information please consult the product for Augtyro on the EMA website.
Gohibic (vilobelimab): has received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
ARDS is a type of lung failure from fluid build-up and is potentially fatal. This can be caused by different disorders in this case from a COVID-19 infection.
Vilobelimab is a monoclonal antibody and binds the complement factor C5a and suppresses the immune response of the body. C5a is a pro-inflammatory protein and part of the natural immune defence. Too much C5a harms the body and leads to sepsis. For more information please consult the product for Gohibic on the EMA website.
Lazcluze (lazertinib): received a positive opinion for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations in combination with amivantamab.
NSCLC is a serious and often fatal disease that accounts for 80 to 85% of all lung cancers. A significant number of patients present with driver mutations in oncogenes, some of which can be aimed at by targeted therapies. Patients without known driver mutations need broader-acting therapies.
Lazertinib is an irreversible inhibitor the mutated epidermal growth factor receptor (EGFR). EGFR interacts with different signal pathways, which regulate cell proliferation and programmed cell death. By blocking EGFR the cell proliferation of the tumour slows. For more information please consult the product for Lazcluze on the EMA website.
Leqembi (lecanemab): has received after re-examination a positive opinion for the treatment of mild cognitive impairment or mild dementia due to early Alzheimer’s disease in patients who have only one or no copy of ApoE4 gene. The EMA released a communication about this re-examination procedure.
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills to a point that simplest tasks are impossible.
Lecanemab is a monoclonal antibody that binds to amyloid beta, which forms plaques in the brain of Alzheimer’s patients. Amyloid plaques are one cause of the disease and by binding to these lecanemab can reduce them and therefore slows the disease progression. For more information please consult the product for Leqembi on the EMA website.
Recommendations on extensions of therapeutic indication:
Cellcept (Mycophenolate mofetil): extension of indication to include paediatric patients (1 to 18 years of age) for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Cellcept is already authorised for adults. For more information please consult the product for Cellcept on the EMA website.
Evkeeza (Evinacumab): extension of indication for EVKEEZA to include the treatment of paediatric patients with homozygous familial hypercholesterolaemia aged 6 months to less than 5 years. Evkeeza is already authorised in adults and children from 5 years. For more information please consult the product for Evkeeza on the EMA website.
Jakavi (ruxolitinib): extension of indication to include of paediatric patients aged 28 days or older with acute and chronic graft versus host disease (GvHD). Jakavi is already authorised in adults. For more information please consult the product for Jakavi on the EMA website.
Kevzara (sarilumab): extension of indication to include the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX. Kevzara is already authorised for rheumatoid arthritis in adults. For more information please consult the product for Kevzara on the EMA website.
Keytruda (pembrolizumab): extension of indication to include the treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma in combination with pemetrexed and platinum chemotherapy. Keytruda is already authorised for various other cancer types and settings. For more information please consult the product for Keytruda on the EMA website.
Opdivo (Nivolumab): extension of indication to include OPDIVO in combination with ipilimumab in the first-line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer. Opdivo is already authorised for a number of other cancer types. For more information please consult the product for Opdivo on the EMA website.
Palforzia (Defatted powder of peanuts): extension of indication to include treatment of patients 1 to 3 years old with a confirmed diagnosis of peanut allergy. Palforzia is already authorised for patients between 4 and 17 years. For more information please consult the product for Palforzia on the EMA website.
Rybrevant (Amivantamab): extension of indication to include amivantamab in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. Rybrevant is already authorised for NSCLC in different settings. For more information please consult the product for Rybrevant on the EMA website.
Sarclisa (Isatuximab): extension of indication to include in combination with bortezomib, lenalidomide, and dexamethasone the treatment of adult patients with newly diagnosed active multiple myeloma who are not eligible for autologous stem cell transplant (ASCT) or with no intent for ASCT as initial therapy. Sarclisa is already authorised for multiple myeloma in different settings. For more information please consult the product for Sarclisa on the EMA website.
Tagrisso (Osimertinib): extension of indication to include treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. Tagrisso is already authorised for NSCLC in different settings. For more information please consult the product for Tagrisso on the EMA website.
Yervoy (Ipilimumab): extension of indication to include YERVOY in combination with nivolumab in the first-line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer. Yervoy is already authorised for a number of other cancer types. For more information please consult the product for Yervoy 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:
Akantior (polihexanide): is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age. EPAR Akantior.
Cejemly (sugemalimab): is indicated for the first-line treatment, in combination with platinum-based chemotherapy, of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations. EPAR Celemly.
Vevizye (ciclosporin): is indicated for the treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. EPAR Vevizye.
Recently started procedures:
- ATROPINE SULFATE PH. EUR. - EMEA/H/C/006385, PUMA, treatment of myopia in children aged 3 years and older.
- Deutivacaftor / Tezacaftor / Vanzacaftor - EMEA/H/C/006382, indicated for the treatment of cystic fibrosis.
- Inavolisib - EMEA/H/C/006353, treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)negative, locally advanced or metastatic breast cancer.
- Octreotide - EMEA/H/C/006322, for treatment of acromegaly in adult patients in whom surgery is inappropriate or ineffective.
- Sepiapterin - EMEA/H/C/006331, Treatment of hyperphenylalaninemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
- Teprotumumab - EMEA/H/C/006396, treatment of moderate to severe Thyroid Eye Disease (TED).
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
