US FDA Onc\Haem Approvals – Medical News Asia

Selpercatinib displays efficacy in RET fusion-positive non-small cell lung cancer

7 September 2020/0 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Chemotherapy, Targeted Therapies/by Kirsty LEE

Aberrant RET activation has shown to be a clinical driver of tumour growth and proliferation. It is reported that 1-2% of non-small cell lung cancer patients have activating RET fusions. Clinical characteristics of these patients are generally younger (<60 years) with minimal or no smoking history, and frequent presentation with brain metastases at diagnosis of advanced disease. RET mutations are mutually exclusive with other common lung cancer genetic abberations, such as reported for KRAS, EGFR, and ALK.

First liquid biopsy for NSCLC to receive FDA approval

7 September 2020/0 Comments/in Breast Cancer, Gastrointestinal Cancer, Genitourinary Cancer, US FDA Onc\Haem Approvals, Gynaecological Cancer, Lung Cancer, Oncology, Targeted Therapies/by Kirsty LEE

The development of new targeted therapies for non-small cell lung cancer (NSCLC) in recent years has changed the standard of care for the later stages of NSCLC in specific population groups.

Venetoclax FDA approved for CLL and SLL

15 May 2019/0 Comments/in US FDA Onc\Haem Approvals, Haematology/by scienterrific

On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.

FDA approves avelumab plus axitinib for renal cell carcinoma

14 May 2019/0 Comments/in Genitourinary Cancer, US FDA Onc\Haem Approvals, Immunotherapy/by Stijn van den Borne, MSc

On 14 May 2019, the FDA approved the combination of avelumab (Bavencio®, Merck KGaA/Pfizer) plus axitinib (Inlyta®, Pfizer) for the first-line treatment of advanced renal cell carcinoma (RCC) patients.

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Ramucirumab FDA approved for hepatocellular carcinoma

10 May 2019/0 Comments/in Gastrointestinal Cancer, US FDA Onc\Haem Approvals, Targeted Therapies/by scienterrific

On 10 May 2019, the FDA approved single agent ramucirumab (Cyramza®, Eli Lilly) for the treatment of hepatocellular carcinoma (HCC) patients previously treated with sorafenib and who have an alpha-fetoproteintein (AFP) of ≥ 400 ng/mL.

T-DM1 FDA approved for early breast cancer

3 May 2019/0 Comments/in Breast Cancer, US FDA Onc\Haem Approvals, Targeted Therapies/by scienterrific

On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.

Ivosidenib FDA-approved as first-line treatment for AML patients with IDH1 mutation

2 May 2019/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

On the 2nd of May 2 2019, the FDA approved ivosidenib (Tibsovo®, Agios) as treatment for newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old and AML patients with comorbidities precluding intensive induction chemotherapy. Patients should harbour a susceptible IDH1 mutation, as per the FDA-approved Abbott RealTime™ IDH1 Assay, to be legible for ivosidenib treatment.

Pembrolizumab plus axitinib FDA approved for the first-line treatment of advanced renal cell carcinoma patients

26 April 2019/0 Comments/in US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Immunotherapy, Targeted Therapies/by scienterrific

On 19 April 2019, the FDA approved the programmed death 1 (PD-1) inhibitor pembrolizumab (KEYTRUDA®, Merck) plus axitinib – a selective and potent receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 – as a first-line treatment for advanced renal cell carcinoma (RCC) patients.

Palbociclib approved for the treatment of male breast cancer

22 April 2019/0 Comments/in Breast Cancer, US FDA Onc\Haem Approvals, Haematology, Oncology, Endocrine Therapy, Targeted Therapies/by scienterrific

On 4 April 2019, the US FDA approved palbociclib (Ibrance®, Pfizer) plus aromatase inhibitor or fulvestrant for the treatment of male patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma

22 April 2019/0 Comments/in Genitourinary Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On 12 April 2019, the FDA granted accelerated approval to erdafitinib (Balversa®, Janssen) for the treatment of locally advanced or metastatic urothelial cell carcinoma (mUCC) progressed during or following a platinum-containing regimen, including progression within 12 months of (neo)adjuvant platinum-based chemotherapy, and whose tumours harbour susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations as determined by the FDA approved companion diagnostic (CDx), the therascreen® FGFR RGQ RT-PCR Kit by Qiagen.