Oncology and onco-hematology

Authorized indications:

ABIRANOVA® in combination with prednisone or prednisolone is indicated for: -The treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). -The treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. -The treatment of mCRPC in adult men whose disease has progressed during or after a docetaxel-based chemotherapy regimen.

Authorized indications:

Ambiful is indicated:

• As monotherapy for the treatment of postmenopausal women with locally advanced or metastatic breast cancer with estrogen receptor-positive: not previously treated with endocrine therapy, or whose disease has recurred during or after antiestrogen adjuvant therapy, or whose disease has progressed on antiestrogen therapy.
• In combination with palbociclib for the treatment of locally advanced or metastatic breast cancer that is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, in women who have received prior hormone therapy. In pre- or perimenopausal women, treatment in combination with palbociclib should be accompanied by a luteinizing hormone-releasing hormone (LHRH) agonist.

Authorized indications:

AXINOVA® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following failure of prior treatment with sunitinib or cytokines.

Authorized indications:

AZANOVA® is indicated for the treatment of adult patients who are not considered candidates for hematopoietic stem cell transplantation (HSCT) and who suffer for: -Intermediate 2 and high-risk myelodysplastic syndromes (MDS), according to the International Prognostic Scoring System (IPSS). -Chronic myelomonocytic leukemia (CMML) with 10 to 29% marrow blasts without myeloproliferative disorder. -Acute myeloid leukemia (AML) with 20 to 30% blasts and multilineage dysplasia, according to the WHO classification. -AML with >30% marrow blasts according to the WHO classification.

Authorized indications:

CAPECINOVA® is indicated for adjuvant treatment after surgery in patients with stage III colon cancer (Dukes stage C) and as monotherapy in the first line of metastatic colorectal cancer. It is also indicated for the first line treatment of advanced gastric cancer with a platinum-containing regimen.

CAPECINOVA® in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. The previous therapy must have included an anthracycline. It is also indicated in monotherapy for patients with locally advanced or metastatic breast cancer after failure with taxanes and a chemotherapeutic regimen that includes an anthracycline or for those patients for whom no further therapy with anthracyclines is indicated.

Authorized indications:

CIPRONOVA® is indicated for non-tumoral female hirsutism and treatment for palliative prostate Cancer

Authorized indications:

DASANOVA® is indicated for the treatment of adult patients with:

• Chronic myeloid leukemia ( CML)with positive Philadelphia chromosome (Ph+) in chronic phase newly diagnosed.
• Chronic, accelerated or blastic phase MCL with resistance or intolerance to previous therapy, including imatinib.
• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and lymphoblastic CML with resistance or intolerance to previous treatment.

DASANOVA® is indicated for the treatment of pediatric patients with:

• Newly diagnosed chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase or chromosome-positive chronic myeloid leukemia (CML).
• Philadelphia positive (Ph+) in chronic phase resistant or intolerant to prior therapy, including imatinib.
• Newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

Authorized indications:

Malignant pleural mesothelioma EKEL® in combination with Cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. Non-small cell lung cancer EKEL® is indicated in combination with Cisplatin for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, except in patients with squamous cell histology. EKEL® is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy, except in patients with squamous cell histology. EKEL® is indicated as monotherapy for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer, except in patients with squamous histology, whose disease has not progressed immediately after a platinum-based chemotherapy regimen.

Authorized indications:

GEFINOVA® is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with epidermal growth factor receptor protein kinase (TK-EGFR) activating mutations.

Gefitinb is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have previously received chemotherapy.

Authorized indications:

• Ovarian cancer: Gemcitabine in combination with carboplatin is indicated in the treatment of patients with locally advanced or metastatic epithelial carcinoma of the ovary with recurrent disease, after a relapse-free interval of at least 6 months After a platinum-based first-line treatment.
• Breast cancer: Gemcitabine is a combination of Paclitaxel is indicated in the treatment of metastatic or locally advanced non-resectable breast cancer, provided that these patients have resorted to prior adjuvant or neoadjuvant chemotherapy treatment. Prior chemotherapeutic treatment should have contained an anthracycline unless it was clinically contraindicated.
• Non-small cell lung cancer: Gemcitabine is indicated in combination with Cisplatin for the first line treatment of patients with inoperable lung cancer, locally advanced (stage IIIA or IIIB) or metastatic (stage IV) of non-small cells.
• Bladder cancer :Gemcitabine is indicated in the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.

Authorized indications:

IMATINOVA® is indicated for the treatment of:

• Adult and pediatric patients with newly diagnosed Philadelphia positive chromosome (Ph+) chronic myeloid leukemia (CML) (bcr-abl) for whom bone marrow transplantation is not considered first-line treatment.
• Adult and pediatric patients with Ph + CML in chronic phase after failure of treatment with interferon-alpha, or in accelerated phase or blast crisis.
• Adult and pediatric patients with newly diagnosed Philadelphia positive chromosome acute lymphoblastic leukemia (Ph+ ALL), integrated with chemotherapy.
• Adult patients with refractory or relapsed Ph+ ALL, as monotherapy.
• Adult patients with myelodysplastic/myeloproliferative syndromes (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangement.
• Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα rearrangement. The effect of IMATINOVA® on the outcome of bone marrow transplantation has not been determined. IMATINOVA® is indicated for:
• Treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
• The adjuvant treatment of adult patients who are at significant risk of relapse after resection of GIST Kit (CD117) positive. Patients who are at low or very low risk of relapse should not receive adjuvant treatment.
• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not candidates for surgery.

Authorized indications:

LAPANOVA® is indicated for the treatment of adult patients with breast cancer whose tumors overexpress HER2 (ErbB2) in combination with:

• Capecitabine for the treatment of patients with advanced or metastatic disease that has progressed following prior therapy, which must have included anthracyclines and taxanes, and treatment with trastuzumab in the metastatic setting.
• Trastuzumab in patients with metastatic disease and hormone receptor-negative status that has progressed on previous therapy/therapies with trastuzumab in combination with chemotherapy.
• Letrozole or other aromatase inhibitors for the treatment of postmenopausal women with metastatic disease, with hormone receptor-positive status, for whom hormonal therapy is indicated. Patients enrolled in the registration study had not been previously treated with trastuzumab or an aromatase inhibitor.

Authorized indications:

Myelodysplastic Syndrome (MDS): LENALINOVA® as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low or Intermediate-1 risk myelodysplastic syndromes linked to an isolated 5q deletion cytogenetic abnormality with or without additional cytogenetic abnormalities when other therapeutic options are insufficient or inadequate. Multiple Myeloma (MM): LENALINOVA® as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. LENALINOVA® in combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see “Posology and method of administration”) is indicated for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not candidates for transplantation. . LENALINOVA® in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. Mantle Cell Lymphoma (MCL): LENALINOVA® as monotherapy is indicated for the treatment of adult patients with mantle cell lymphoma (MCL), who have relapsed or progressed after receiving two prior therapies, in one of the which Bortezomib has been used. Follicular Lymphoma: LENALINOVA® in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients who have received prior treatment for follicular lymphoma (Grade 1-3a).

Consent form available here.

Authorized indications:

OGIVRI® is indicated for:

The adjuvant treatment of HER2-overexpressing breast cancer with node-positive or node-negative (ER/PR-negative or with one high-risk feature) disease

• As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and paclitaxel or docetaxel
• As part of a treatment regimen with docetaxel and carboplatin
• As monotherapy following multimodal anthracycline-based therapy. The treatment of HER2-overexpressing metastatic breast cancer
• In combination with paclitaxel for first-line treatment
• As monotherapy in patients who have received one or more chemotherapy regimens for their metastatic disease.

The treatment of metastatic gastric cancer, in combination with cisplatin and capecitabine or 5-fluorouracil, in patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for their metastatic disease.

Authorized indications:

• Ovarian carcinoma Paclitaxel is indicated, in combination with cisplatin, as first-line chemotherapy for the treatment of patients with advanced ovarian carcinoma or residual disease (>1 cm) after initial laparotomy. Paclitaxel is indicated for second-line chemotherapy of ovarian carcinoma, for the treatment of metastatic ovarian carcinoma after failure of standard platinum-based therapy.
• Breast carcinoma In the adjuvant treatment, paclitaxel is indicated for the treatment of patients with node-positive breast carcinoma after receiving the combination of anthracycline and cyclophosphamide (AC therapy). Adjuvant treatment with paclitaxel should be considered as an alternative to continuing AC treatment. Paclitaxel is indicated for the initial treatment of patients with locally advanced or metastatic breast cancer, either in combination with an anthracycline in patients for whom anthracycline therapy is indicated or in combination with trastuzumab, in patients whose tumors have overexpression of HER2 in rank 3+ determined by immunohistochemistry and in which treatment with anthracyclines is not indicated. As a single agent, paclitaxel is indicated for the treatment of metastatic carcinoma of the breast in patients who have failed or are not candidates for standard anthracycline-based therapy.
• Advanced non-small cell lung carcinoma (NSCLC) Paclitaxel, in combination with cisplatin, is indicated for the treatment of non-small cell lung carcinoma in patients who are not candidates for potentially curative surgery and/or radiotherapy. • Kaposi's sarcoma linked to AIDS Paclitaxel is indicated for the treatment of patients with AIDS-related advanced Kaposi's sarcoma (KS) for whom prior liposomal anthracycline therapy has failed.

Authorized indications:

First-line and subsequent therapy for the treatment of advanced ovarian carcinoma. As first-line therapy, Paclitaxel treatment is indicated in combination with cisplatin. Adjuvant treatment of breast cancer positive nodule, administered sequentially, with standard chemotherapy with combined doxorubicin. Treatment of breast cancer in cases where combined chemotherapy for metastasica disease or recurrence had failed within 6 months of adjuvant therapy. Pre-treatment should have included an anthracycline, unless it is clinically contraindicated. Paclitaxel, combined with cisplatin, is indicated as the first line of treatment for non-small cell lung cancer in patients unfit for potentially curative surgery and/or radiotherapy. Second line of treatment for AIDS-related Kaposi’s Sarcoma.

Authorized indications:

Treatment of patients with recent diagnosis of glioblastoma multiforme concomitantly with radiotherapy and later as adjuvant therapy, treatment of patients with malignant glioblastoma, such as glioblastoma multiforme or astrocytoma Anaplastic that present recurrence or progression after conventional therapy.

Authorized indications:

Bone metabolism regulator. Treatment of osteolytic and mixed bone metastases from solid tumors and osteolytic lesions of multiple myeloma, in conjunction with conventional antineoplastic therapy. Treatment of hypercalcaemia of malignant neoplasia (HM). therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.