ROCHE SINGAPORE PTE. LTD.

**2.1 THERAPEUTIC INDICATION(S)** **_Non-Small Cell Lung Cancer (NSCLC)_** Gavreto is indicated for the treatment of adult patients with rearranged during transfection ( _RET_) fusion-positive, locally advanced or metastatic NSCLC. _**RET-Mutant Medullary Thyroid Cancer (MTC)**_ Gavreto is indicated for the treatment of adult patients with locally advanced or metastatic _RET_-mutant MTC who require systemic therapy.

**2.1 THERAPEUTIC INDICATION(S)** Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescents who are anti-aquaporin 4 (AQP4) seropositive.

<p><strong>2.1 THERAPEUTIC INDICATION(S)</strong><br> Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).</p> <p>Polivy in combination with bendamustine and MabThera is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for haematopoietic cell transplant.</p>

<p><strong>2.1 THERAPEUTIC INDICATION(S)</strong></p> <p>Cotellic is indicated for use in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation.</p>

<p><strong>2.1 Therapeutic Indications</strong><br> <em><strong>Herceptin IV and Herceptin SC</strong></em><br> <em>Metastatic Breast Cancer (MBC)</em><br> Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2:</p> <ol class="alphaparen"> <li>as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease</li> <li>in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease</li> <li>in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with Herceptin. This indication is based on data from one Phase III trial which studied the use of Herceptin in combination with anastrozole (see 3.1.2 Clinical / Efficacy Studies &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Experience with other aromatase inhibitors is limited.</li> </ol> <p><em>Early Breast Cancer (EBC)</em><br> Herceptin is indicated for the treatment of patients with HER2 positive early breast cancer.</p> <ul class="dash"> <li>following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 3.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li> <li>following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.</li> <li>in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.</li> <li>in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours &gt; 2 cm in diameter (see sections 2.4 and 3.1 &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li> </ul> <p>Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.</p> <p><strong><em>Herceptin IV only</em></strong><br> <em>Metastatic Gastric Cancer (MGC)</em><br> Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.</p> <p>Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.</p>

**2.1 Therapeutic indications** Metastatic Breast Cancer (MBC) Perjeta is indicated for use in combination with Herceptin and docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Early Breast Cancer Perjeta is indicated for use in combination with Herceptin and chemotherapy for the: - neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival. - adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (see section 3.1.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

<p><strong>2.1 Therapeutic Indication(s)</strong><br> <strong><u><em>MabThera IV and MabThera SC</em></u></strong><br> <strong>Non-Hodgkin&rsquo;s Lymphoma:</strong><br> MabThera IV and MabThera SC are indicated for the treatment of:</p> <ul> <li>patients with CD20 positive diffuse large B-cell non-Hodgkin&rsquo;s lymphoma (DLCL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy.</li> <li>previously untreated patients with stage III&ndash;IV follicular lymphoma in combination with CVP chemotherapy.</li> </ul> <p>MabThera IV and MabThera SC maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.</p> <p><strong><em><u>MabThera IV only</u></em></strong><br> <strong>Non-Hodgkin&rsquo;s Lymphoma:</strong><br> MabThera IV is indicated for the treatment of patients with relapsed or chemoresistant indolent B-cell non-Hodgkin&rsquo;s lymphomas.</p> <p><strong>Chronic Lymphocytic Leukaemia:</strong><br> MabThera IV is indicated in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.</p> <p><strong><em>Rheumatoid Arthritis:</em></strong><br> MabThera IV in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.</p>

**4.1. Therapeutic indications** Treatment of anaemia associated with chronic kidney disease (CKD). The safety and efficacy of MIRCERA therapy in other indications has not been established, therefore such use is not recommended.

<p><strong>4.1. Therapeutic indications</strong><br> Treatment of anaemia associated with chronic kidney disease (CKD). The safety and efficacy of MIRCERA therapy in other indications has not been established, therefore such use is not recommended.</p>

**4.1. Therapeutic indications** Treatment of anaemia associated with chronic kidney disease (CKD). The safety and efficacy of MIRCERA therapy in other indications has not been established, therefore such use is not recommended.