AVAMAB CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/4MLHSA
<p><strong>Therapeutic Indications</strong><br>
<em>Metastatic carcinoma of the colon or rectum(mCRC)</em><br>
Avamab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.</p>
<p><em>Metastatic Breast Cancer (mBC)</em><br>
Avamab in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. Avamab in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avamab in combination with capecitabine. The effectiveness of Avamab in metastatic breast cancer (mBC) is based on an improvement in progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avamab in breast cancer.</p>
<p><em>Non-Small Cell Lung Cancer (NSCLC)</em><br>
Avamab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Avamab, in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.</p>
<p><em>Malignant Glioma (WHO Grade IV) – Glioblastoma</em><br>
Avamab, as a single agent is indicated for the treatment of patients with glioblastoma after relapse or disease progression following prior therapy. The effectiveness of Avamab in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with Avamab.</p>
<p><em>Advanced and/or metastatic Renal Cell Cancer (mRCC)</em><br>
Avamab in combination with interferon alfa-2a is indicated for first-line treatment of patients with advanced and/or metastatic renal cell cancer.</p>
<p><em>Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer</em><br>
Avamab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Avamab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.</p>
<p>Avamab in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.</p>
<p><em>Cervical Cancer</em><br>
Avamab in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.</p>
