Xospata Unia Europejska - polski - EMA (European Medicines Agency)

xospata

astellas pharma europe b.v. - gilteritinib fumaran - białaczka, szpikowe, ostre - Środki przeciwnowotworowe - xospata jest wskazany w monoterapii w leczeniu dorosłych pacjentów z nawrotem lub oporną na leczenie ostrej białaczki szpikowej (aml) z mutacją flt3 w .

Ayvakyt Unia Europejska - polski - EMA (European Medicines Agency)

ayvakyt

blueprint medicines (netherlands) b.v. - avapritinib - guzy stromal żołądkowo-jelitowe - inne leki przeciwnowotworowe, inhibitory białka kinazy - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

Kaftrio Unia Europejska - polski - EMA (European Medicines Agency)

kaftrio

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Enhertu Unia Europejska - polski - EMA (European Medicines Agency)

enhertu

daiichi sankyo europe gmbh - trastuzumab deruxtecan - nowotwory piersi - Środki przeciwnowotworowe - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Skysona Unia Europejska - polski - EMA (European Medicines Agency)

skysona

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - inne leki na układ nerwowy - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Tabrecta Unia Europejska - polski - EMA (European Medicines Agency)

tabrecta

novartis europharm limited  - capmatinib dihydrochloride monohydrate - rak, niedrobnokomórkowe płuca - Środki przeciwnowotworowe - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Orserdu Unia Europejska - polski - EMA (European Medicines Agency)

orserdu

stemline therapeutics b.v. - elacestrant - nowotwory piersi - terapia endokrynologiczna - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.