Oncology – Page 10 – Medical News Asia

Pembrolizumab FDA approved for adjuvant treatment of melanoma

16 February 2019/0 Comments/in US FDA Onc\Haem Approvals, Oncology, Melanoma & Skin Cancer, Immunotherapy, Surgery/by scienterrific

On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.

Trastuzumab-biosimilar Ontruzant® FDA approved in several indications

21 January 2019/0 Comments/in Breast Cancer, Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.

Cabozantinib FDA approved in HCC patients failing sorafenib

17 January 2019/0 Comments/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.

Erasmus University MC investigating a new surgical matrix to reduce post-operative complications

16 January 2019/0 Comments/in Medical News Asia, Oncology, Surgery/by Stijn van den Borne, MSc

The synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala − Sweden) might be an interesting candidate for the prevention of complications frequently observed with permanent mesh placement, according to Professor Johan Lange of the Erasmus University in Rotterdam − the Netherlands.

Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma

14 January 2019/0 Comments/in US FDA Onc\Haem Approvals, Melanoma & Skin Cancer, Oncology, Immunotherapy/by Stijn van den Borne, MSc

On 19 December 2018, pembrolizumab (Keytruda®, Merck) received accelerated approval by the FDA for the treatment of recurrent locally advanced or metastatic (R/M) Merkel cell carcinoma (MCC) in adult and paediatric patients.

Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

27 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Paediatric/by scienterrific

On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

27 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Paediatric/by scienterrific

On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer

22 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Gynaecological Cancer, Oncology, Targeted Therapies/by scienterrific

On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).

Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer

21 December 2018/0 Comments/in Breast Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.

Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC

11 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Chemotherapy, Immunotherapy, Targeted Therapies/by scienterrific

On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.