AEMPS begins to evaluate Itavebi for breast cancer

The Spanish Agency for Medicines and Health Products (AEMPS) on Monday has reported the start of the work to prepare the therapeutic positioning reports (IPT) of ‘Itavebi’ (Inavolisib), for breast cancer with mutation in the Pik3ca gene, and four new drugs, as well as two new indications.

The agency assigned to the Ministry of Health will begin to Evaluate the efficacy, security, cost-effectivity and impact in the health of the four new medicines and two indication extensions obtained last May the positive opinion of the Human Use Medicines Committee (CHMP), of the European Medicines Agency (EMA).

Among them, ‘Itavebi’, by Roche, in combination with Palbociclib and Fulvestrantis indicated for the treatment of adult patients with locally advanced or metastatic breast cancer, with mutation in the pik3ca gene, positive estrogen receiver (re) and her2 negative, after recurrence during or in the 12 months following the completion of the adjuvant endocrine treatment.

In addition, the AEMPS will value ‘Aucatzyl’ (Obecabtagén Autoleuce), of Autolus, for the treatment of adult patients of 26 years and older with acute lymphoblastic leukemia of precursor precursors of B (lla b) refractory or in relapse (R/r); and ‘Ezmekly’ (Mixetinib), of Springworks Therapeutics, indicated in monotherapy for the treatment of plexiform neurofibromas (NP) symptomatic and inoperable in pediatric patients from 2 years of age and adults with type 1 neurofibromatosis (NF1).

Next to these, ‘Blenrep’ (Belantamab mafodotin), of glaxosmithkline trading, for the treatment of multiple myeloma in relapse or refractory, both in combination with bortezomib and dexamethasone in patients who have received at least one previous treatment, as in combination with pomalidomide and dexamethasone in patients who have received at least one previous treatment including Lenalidomide.

Will also work at the IPT for ‘Maapliv’, of remembrance, for the treatment of urine disease with the smell of arce syrup (eooja) that occurs in the form of acute episodes of decompensation in patients since birth that are not suitable for oral or enteral formulations free of branched chain amino acids.

New indications

On the other hand, the AEMPS has reported the start of the work of therapeutic positioning reports for new indications of ‘Imfinzi’ (Durvalumab) and ‘Tevimbra’ (Tislelizumab), which also received the approval of the EMA.

The new indication for ‘imfinzi’ is, in combination with gemcitabine and cisplatino, as neoadjuvant treatment, followed by ‘imfinzi’ in monotherapy as a adjuvant treatment after the Radical cistectomyfor the treatment of adults with invasive muscle bladder cancer (CVMI).

As for ‘Tevimbra’, the expansion of its use will be assessed, in combination with gemcitabine and cisplatin, For the first -line treatment of adult patients with recurrent nasopharyngeal carcinoma (CNF), not susceptible to healing surgery or radiotherapy, or metastatic.