US FDA Onc\Haem Approvals – Page 6 – Medical News Asia

Enzalutamide FDA approved for castration-resistant prostate cancer (CRPC)

17 July 2018/0 Comments/in US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Endocrine Therapy/by scienterrific

On July 13, the FDA approved enzalutamide (Xtandi©, Astellas), for use in patients with castration-resistant prostate cancer (CRPC).

Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC

11 July 2018/2 Comments/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Immunotherapy/by scienterrific

On July 10th, the FDA granted accelerated approval to ipilimumab (Yervoy©, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo©) for the treatment of adult and paediatric patients ≥12 years of age with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved

2 July 2018/0 Comments/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On June 27th, the FDA approved Array Biomarpharma’s combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.

FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

19 June 2018/1 Comment/in US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Immunotherapy, Translational Research/by scienterrific

On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.

Bevacizumab in combination with carboplatin and paclitaxel FDA approved for several types of gynaecological cancers

14 June 2018/0 Comments/in US FDA Onc\Haem Approvals, Gynaecological Cancer, Oncology, Chemotherapy, Targeted Therapies/by scienterrific

On June 13, 2018, the FDA approved bevacizumab (AvastinⓇ, Genentech, Inc.) in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab for use after surgical resection in patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients

14 June 2018/1 Comment/in US FDA Onc\Haem Approvals, Haematology, Oncology, Immunotherapy/by scienterrific

On June 13, 2018, the US FDA has granted accelerated approval to pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL), relapsed after two or more prior lines of prior therapy.

FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1

13 June 2018/0 Comments/in US FDA Onc\Haem Approvals, Gynaecological Cancer, Oncology, Immunotherapy, Translational Research/by scienterrific

On June 12, 2018 the FDA approved pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for patients with chemotherapy-refractory recurrent or metastatic (r/m) cervical cancer and with a combined positive score (CPS)≥1 PD-L1 level expression.

FDA approves venetoclax in 2nd-line for patients with CLL or SLL

9 June 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

FDA granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

6 June 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, AE Management/by scienterrific

FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers.

FDA approved avatrombopag for thrombocytopenia in CLD patients scheduled for a procedure

21 May 2018/1 Comment/in US FDA Onc\Haem Approvals, Uncategorised/by scienterrific

On May 21, the FDA approved avatrombopag (DopteletⓇ, AkaRx Inc.) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a procedure.