Rome, 18 November – The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of marketing authorization to eight new medicines nits last meeting, held last November 11-14. meeting in November 2024, thus bringing the total number of drugs approved so far in the current year to 97.
These are the “promoted” drugs: the release of a conditional MA was requested for Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents with advanced solid tumors and adults with locally advanced or metastatic non-small cell lung cancer. Marketing authorization recommended in exceptional circumstances also for Gohibic (vilobelimab), for the treatment of adult patients with Sars CoV 2-induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard therapy and undergoing invasive mechanical ventilation with or without extracorporeal membrane oxygenation (for the evaluation of this drug the EMA emergency task force was consulted). Positive opinion also for Lazcluze (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer in combination with amivantamab.
The CHMP also recommended positive opinions for four biosimilar medicines: Baima (aflibercept) and its duplicate Ahzantivefor the treatment of neovascular age-related macular degeneration and vision impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, or myopic choroidal neovascularization; Obodence (denosumab), to treat osteoporosis and bone loss e Xbryk (denosumab), for the prevention of skeletal-related events in adults with advanced malignancies involving bone and the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
In terms of extensions of therapeutic indications, the Committee recommended them for 11 medicines already authorized in the EU: CellCept, Evkeeza, Jakavi, Kevzara, Keytruda, Opdivo, Palforzia, Rybrevant, Sarclisa, Tagrisso e Yervoy.
However, there is no shortage of negative opinions, with the refusal to issue the AICI, expressed for two medicines: these are Chinese (allium/citrus/paullinia/cocoa), a medicine intended for the treatment of moderate to severe alopecia areata, a disease causing hair loss from the scalp or other parts of the body, and Kizfizo (temozolomide), for the treatment of neuroblastoma, a rare tumor that forms from immature nerve cells.
Afterthought on Lecanemabdrug for Alzheimer’s: MA granted
Following a review, the CHMP recommended granting a marketing authorization for This teami (lecanemab), to treat mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copies of ApoE4, a certain form of gene for the apolipoprotein E protein. During the review, the company applying for the MA provided additional data analysis to support the proposed use in a subgroup of patients. The Committee concluded that in the restricted population of patients who have only one or no copies of ApoE4, the benefits of This group outweigh the risks (further information here).
After reviewing its initial opinion, the CHMP also recommended updating the advice aimed at minimizing the risks of interaction between Mysimba (naltrexone/bupropion), indicated for weight loss Mysimba (naltrexone/bupropion) and medicines containing opioids, including painkillers such as morphine and codeine, other opioids used during surgery, and some cough, cold, or diarrhea medicines. We report on it more extensively in this article.
How do the newly approved biosimilars and therapeutic extensions impact treatment options for patients with eye diseases and cancer-related bone loss?
Interviewer: Our first guest today is Dr. Jane Smith, a leading medical expert specializing in oncology and drug development, and our second guest is Dr. Sarah Lee, a health policy analyst with extensive experience in regulatory affairs. Thank you both for being here today.
We’d like to discuss the recent announcement by the European Medicines Agency (EMA) regarding the approval of eight new medicines. Dr. Smith, could you provide us with an overview of these newly approved drugs and their potential impact on cancer treatment?
Dr. Smith: Of course. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to eight new medicines, including Augtyro (repotrectinib) for treating adults and adolescents with advanced solid tumors and adults with locally advanced or metastatic non-small cell lung cancer. This drug blocks the activity of certain abnormal proteins in cancer cells, leading to cell death.
Another medicine, Gohibic (vilobelimab), has been recommended for the treatment of adult patients with severe respiratory failure due to COVID-19 infection. This drug is a monoclonal antibody that targets a particular protein on the surface of immune cells to help them recognize and destroy infected cells.
Lazcluze (lazertinib) received a positive opinion for first-line treatment of advanced non-small cell lung cancer, where it can be combined with another drug called amivantamab. This drug blocks the activity of certain proteins involved in cell growth and division, leading to cell death in cancer cells.
In terms of biosimilars, the CHMP recommended Baima (aflibercept) and its duplicate Ahzantive for the treatment of various eye diseases and Obodence (denosumab) and Xbryk (denosumab) for osteoporosis and bone loss related to certain cancers or their treatments.
In terms of extensions of therapeutic indications, the CHMP recommended additional uses for eleven medicines
