Spanish Agency for Medicines and Health Products (AEMPS) published a total of six new positioning therapy (IPT) reports on Tuesday. In this case, diseases such as COPD or urothelial cancer are distinguished.
Firstly, it was studied dupilumab (Dupixent) in the adjunctive maintenance treatment of uncontrolled chronic obstructive pulmonary disease (COPD), characterized by elevated blood eosinophils, in combination with an inhaled corticosteroid (ICS), a long-acting beta-2 adrenergic agonist (LABA) and a long-acting muscarinic antagonist. LAMA) or in combination with LABA and LAMA if CEI is not suitable.
In this case, the Report determines that the safety profile is similar to that known for other previously approved indications, with infections, gastrointestinal and respiratory disorders being the most common PVLNDs; and that dupilumab is the only approved treatment option
for this type of patient.This is the latest therapeutic positioning report for 2024.
Secondly, we have nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma. Here we see that the indications are limited to the combination of nivolumab with cisplatin and gemcitabine, since its combination with other chemotherapy regimens including carboplatin or the MVAC regimen has not been studied.
Next we have the case idecabtagene vicleucel (Abecma) in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and who have had disease progression during their last treatment.
It is noted here that “it is represented as treatment that has shown significant therapeutic improvement and it is considered a treatment that, when used alone, appears to be more effective in a relatively young, pretreated population with good functional status than other treatments approved in clinical practice in this area.”
New ITPs are aimed at treating COPD, urothelial carcinoma, multiple myeloma, hidradenitis suppurativa, invasive candidiasis and ulcerative colitis.
The fourth IPT will be bimekizumab (Bimzelx) for hidradenitis suppurativa with an inadequate response to traditional systemic treatment. “Bimekizumab is indicated for the treatment of moderate to severe HS (acneversion) in adults who have had an inadequate response to conventional systemic HS treatment,” it concludes.
Likewise, we will have IPT rezafungin (Rezaio) in the treatment of invasive candidiasis in adults. “Based on the current evidence, rezafungin is considered an option for the treatment of invasive candidiasis at the same level as other echinocandins,” they explain.
Finally I would etrasimod (Velsipity) for moderate to severe active ulcerative colitis in patients 16 years of age or older who have had an inadequate response, have experienced loss of response, or are intolerant to conventional treatment or a biologic. It states that “etrasimod is considered a treatment option for patients aged 16 years and older with moderate to severe active ulcerative colitis who have had an inadequate response, have lost response, or are intolerant to conventional treatment or a biologic.” “.