At its May 30 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) endorsed the approval of several cancer therapies.
Cejemly
The drug review panel recommended granting marketing authorization for Cejemly (sugemalimab, SFL Pharmaceuticals Deutschland GmbH), intended for the first-line treatment of metastatic non–small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy.
Lung cancer continues to be the leading cause of cancer-related deaths in Europe, resulting in a significant number of fatalities. Around 80% of all lung cancers are NSCLC, and about 55%-70% of patients with NSCLC are diagnosed with metastatic disease at the time of presentation.
Cejemly is a fully human, anti–programmed death–ligand 1 (PD-L1) immunoglobulin (Ig)–G4 monoclonal antibody. It is indicated for the first ‑ line treatment of adults with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1, or RET genomic tumor aberrations.
The CHMP recommendation is based on positive results from the GEMSTONE-302 trial, which demonstrated significant and clinically meaningful progression-free survival and overall survival improvement with Cejemly plus chemotherapy compared with placebo plus chemotherapy in patients with previously untreated squamous and nonsquamous metastatic NSCLC.
The most common side effects of Cejemly include anemia (77.5%) and increase in aspartate aminotransferase (34.0%) and alanine aminotransferase (32.0%) levels.
Cejemly will be available as a 600-mg concentrate for solution for infusion. Its active substance is sugemalimab, an antineoplastic monoclonal antibody that potentiates T-cell responses, including antitumor responses, by blocking programmed cell death protein 1 binding to PD-L1 ligands.
Avzivi
Avzivi, a bevacizumab biosimilar, received a positive opinion for the treatment of carcinoma of the colon or rectum; breast cancer; NSCLC; renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; and carcinoma of the cervix.
Avzivi is highly similar to the reference product Avastin, which was authorized in the European Union in 2005. It has comparable efficacy, safety and immunogenicity to Avastin, as demonstrated in a phase 3 comparative study.
Its approved indications are for:
Metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine-based chemotherapy for the treatment of adults.Metastatic breast cancer:In combination with paclitaxel for first-line treatmentIn combination with capecitabine for first-line treatment in patients for whom other chemotherapy options, including taxanes or anthracyclines, are not appropriate. Patients treated with taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excludedNSCLC:In combination with platinum-based chemotherapy for first-line treatment of adults with unresectable advanced, metastatic, or recurrent NSCLC other than predominantly squamous cell histologyIn combination with erlotinib for first-line treatment of adults with unresectable advanced, metastatic, or recurrent nonsquamous NSCLC with EGFR activating mutationsRenal cell cancer in combination with interferon alfa-2a for first-line treatment of adults with advanced or metastatic disease.Ovarian, fallopian tube, or primary peritoneal cancer:In combination with carboplatin and paclitaxel for the front-line treatment of adults with advanced diseaseIn combination with carboplatin and gemcitabine or carboplatin and paclitaxel for treatment of adults with first recurrence of platinum-sensitive disease who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agentsIn combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of adults with platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agentsCarcinoma of the cervix in combination with paclitaxel and cisplatin, or alternatively paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adults with persistent, recurrent, or metastatic disease.
Avzivi will be available as a 25-mg/mL concentrate for solution for infusion. Its active ingredient, bevacizumab, is a monoclonal antibody that binds to VEGF. By inhibiting VEGF binding to its receptors on endothelial cells, it neutralizes VEGF’s biologic activity. This action leads to tumor vascular regression, normalization of remaining tumor vasculature, and inhibition of new tumor vasculature formation, ultimately inhibiting tumor growth.
Generics
The CHMP has also given a positive recommendation for five generic medicines for cancer therapy.
Apexelsin (paclitaxel) is for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and NSCLC.
It is a generic version of Abraxane, an albumin-bound paclitaxel nanoparticle, authorized in the European Union since 2008. Studies confirm the quality of Apexelsin, and a bioequivalence study was not required due to its rapid nanoparticle dissociation on intravenous administration and the qualitative and quantitative similarity to the reference product.
Apexelsin monotherapy treats metastatic breast cancer in adults who did not respond to first-line treatment and can’t have standard anthracycline therapy. When combined with gemcitabine, it is indicated for first-line treatment of adults with metastatic pancreatic adenocarcinoma. In addition, alongside carboplatin, Apexelsin is prescribed for first-line treatment of NSCLC in adults ineligible for potentially curative surgery or radiation therapy.
Apexelsin will be available as a 5-mg/mL powder for dispersion for infusion. Its active ingredient, paclitaxel, is a taxane antineoplastic agent. It works by disrupting microtubule growth, leading to cell division inhibition and apoptosis induction. It also affects noncancer cells, potentially causing side effects.
The panel also endorsed Pomalidomide Accord (pomalidomide), Pomalidomide Krka (pomalidomide), and Pomalidomide Zentiva (pomalidomide) for treating multiple myeloma. These will be available in 1-, 2-, 3-, and 4-mg hard capsules. The active substance pomalidomide, an immunomodulator, acts through cytokine modulation, T-cell proliferation induction, inhibition of multiple myeloma cell proliferation, and angiogenesis inhibition.
As generics of Imnovid, authorized in the European Union since 2013, these drugs demonstrated satisfactory quality and bioequivalence to the reference product (Imnovid).
Dasatinib (Accord Healthcare) was also recommended for approval for the treatment of chronic myelogenous leukemia.
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