US FDA Onc\Haem Approvals – Page 5 – Medical News Asia

Venetoclax FDA label updated to include Minimal Residual Disease negativity data

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

On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.

Pembrolizumab and atezolizumab USPIs updated by FDA

21 August 2018/1 Comment/in US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Immunotherapy/by scienterrific

On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

21 August 2018/0 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Immunotherapy/by scienterrific

On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.

Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous NSCLC

21 August 2018/2 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Immunotherapy/by scienterrific

On 20th of August 2018, the FDA granted regular approval for pembrolizumab (Keytruda®, Merck) plus pemetrexed and a platinum salt in the first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), not harbouring any EGFR or ALK genomic tumour aberrations.

Lenvatinib FDA approved for 1st-line treatment of HCC

18 August 2018/1 Comment/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On August 16, 2018 the FDA approved lenvatinib (Lenvima®, Eisai) for the first-line treatment of hepatocellular carcinoma (HCC) patients not amenable for curative surgery.

FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL

9 August 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Chemotherapy/by scienterrific

On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours

31 July 2018/0 Comments/in US FDA Onc\Haem Approvals, Oncology, Radioactive Drugs/by scienterrific

On July 30, 2018, the FDA approved iobenguane I-131 (Azedra®, Progenics Pharmaceuticals), a radioactive therapeutic agent, for the treatment of adult and paediatric patients ≥12 years with iobenguane scan positive, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) not amenable to surgery and indicated for systemic therapy.

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

23 July 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Targeted Therapies/by scienterrific

On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

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

On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.

Ribociclib FDA label updated to include pre- and perimenopausal women

19 July 2018/0 Comments/in Breast Cancer, US FDA Onc\Haem Approvals, Oncology, Endocrine Therapy, Targeted Therapies/by scienterrific

On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis) approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.