Lynparza Ευρωπαϊκή Ένωση - Πολωνικά - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - nowotwory jajnika - Środki przeciwnowotworowe - jajników cancerlynparza jest wskazany w monoterapii w celu:leczenia zachowawczego pacjentów dorosłych z późnymi (figo etapy iii i iv) w genach brca1/2-zmutowane (embrionalna linii i/lub somatycznych) łączony nabłonka jajnika, jajowodu lub pierwotnego dootrzewnowa raka, które w odpowiedzi (pełny lub częściowy) po zakończeniu pierwszej linii na bazie platyny chemioterapii. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 i 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacjenci muszą wcześniej zostały przetworzone z антрациклина i таксана w (neo)adiuwant lub przerzutów, jeśli pacjenci nie nadają się do tych procedur (patrz rozdział 5. pacjenci z receptorem hormonu (h)-dodatniego raka piersi należy również rozwijali lub po wstępnej terapii hormonalnej, lub uważane za nieodpowiednie dla dokrewnego. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Xtandi Ευρωπαϊκή Ένωση - Πολωνικά - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamid - nowotwory stercza - terapia endokrynologiczna - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Xospata Ευρωπαϊκή Ένωση - Πολωνικά - 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 .

Nubeqa Ευρωπαϊκή Ένωση - Πολωνικά - EMA (European Medicines Agency)

nubeqa

bayer ag - darolutamide - nowotwory gruczołu krokowego, odpornego Łożysko - terapia endokrynologiczna - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.