Posts

Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer

On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).

PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer

On October 16, 2018, the FDA approved PARP-inhibitor talazoparib (Talzenna®, Pfizer) for use in patients with deleterious or suspected deleterious germline BRCA-mutated locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients should be selected for the PARP inhibitor (PARPi)-treatment using an FDA-approved companion diagnostic (CDx) for talazoparib.

Pembrolizumab and atezolizumab USPIs updated by FDA

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.

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

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.

FoundationOne companion diagnostic FDA approved

On 30 November 2017, the FDA granted marketing approval for the FoundationOne companion diagnostic (F1CDx®, Foundation Medicine), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumour.

us-fda-approval-medipaper-medical-communications-agency-medical-writer-agency-apac-asia-pacific-HK-hong-kong-oncology-CV-neurology-immunotherapy-obesity-diabetes-specialty-infectious.jpg

Pembrolizumab approved for advanced gastric cancer

On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine– and platinum-containing regimen, and, when appropriate, HER2targeted therapy.