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U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 11-Dec-2018

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

innovent biologics anti-pd1 sintilimab plus biosimilar bevacizumab receive ind status by china nmpa

Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA

SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib vs EGFR-TKI in Asian patients with advanced NSCLC

First-line osimertinib was associated with a clinically meaningful progression-free survival (PFS) improvement when compared to a standard-of-care (SOC) epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) in a sub-analysis of Asian patients who participated in the FLAURA trial (NCT02296125).

Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia

On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).

Capmatinib plus gefitinib promising in MET-dysregulated NSCLC

The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Osimertinib in patients with T790M-positive advanced non-small cell lung cancer and brain metastases (AURA3)

Osimertinib is active in the second-line treatment of patients with T790M-positive advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, as reported by the investigators of the Phase III AURA3 study.

Ribociclib FDA label updated to include pre- and perimenopausal women

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.

ASCO 2018 NSCLC: The ASCO18 Lung Cancer Track Summarised

Non-small cell lung cancer (NSCLC): a key feature of the American Society of Clinical Oncology (ASCO) 2018 annual meeting. This year, encouraging results with single-agent immunotherapy (I-O) and combinations of I-O with chemotherapy (CTx), including the CheckMate 227 with nivolumab (NIVO), IMpower131 and IMpower150 studies with atezolizumab (ATEZO), and KEYNOTE-042 and KEYNOTE-407 studies with pembrolizumab (PEMBRO). Furthermore, important Asian data on treatments for epidermal growth-factor recptor (EGFR) mutation-positive (mu+) NSCLC (ARCHER 1050, NEJ009, NEJ026, and JO25567).

ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised

Breast cancer: a front-runner when it comes to the development of novel therapeutic strategies. With the advent of newer targeted- and immunotherapies, oncologists have an increment of options to offer their patients. The American Society of Clinical Oncology’s (ASCO) 2018 Breast Cancer track offered an extensive look at the latest advancements and updates from on-going trials covering the various subtypes of breast cancer.

FDA approved osimertinib for the 1st-line treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutations positive metastatic non-small cell lung cancer (NSCLC)

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FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Making sense of immunotherapy in NSCLC

Making sense of 1st-line immunotherapy in non-small cell lung cancer (NSCLC)

The expansion of therapeutic options with immunotherapies will reflect a dramatic change in the guidelines for lung cancer, where immunotherapies mostly compete with the use of chemotherapeutic agents. A brief communication on immunotherapies for NSCLC.

FDA approved durvalumab as maintenace for unresectable stage III NSCLC responding to platinum-based chemoradiation therapy

 

FDA granted regular approval to olaparib in the treatment of (suspected) deleterious germline BRCA-mutated, HER2-negative MBC

 

 

Acalabrutinib FDA approved for treatment of adult patients with pre-treated mantle cell lymphoma

On 31 October 2017, the FDA granted accelerated approval to acalabrutinib (Calquence®, AstraZeneca under license of Acerta Pharma BV) for treatment of adult patients with mantle cell lymphoma (MCL) and pre-treated with one or more prior therapy.

HKBCF luminal breast cancer can cdk46 inhibition by palbociclib improve on chemotherapy medipaper medical writer hong kong

Luminal Breast Cancer: can CDK4/6 Inhibition by Palbociclib Improve on Chemotherapy?

Can chemotherapy be avoided in women with hormone-sensitive breast cancer? This is a prominent question in the treatment of breast cancer around the globe.

Abemaciclib in combination with fulvestrant FDA approved for HR+, HER2- advanced or metastatic breast cancer progressing following endocrine therapy

On 28 September 2017, the FDA approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

scientific symposium highlights optimisation of aerosol delivery in patients with poor asthma control aerosol delivery asthma

Optimisation of aerosol delivery in patients with poor asthma control

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PD-L1 Biomarker for Response DAKO 22C3 - MediPaper Medical Communications

PD-L1 Biomarker: a Comparison of ASCO2016 PD-1 and PD-L1 Data

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ESMO 2016 durvalumab avelumab tremelimumab data medipaper medical communications

ESMO16 Durvalumab, Avelumab, Tremelimumab Data – Download the PPT

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ASCO 2016 Avelumab Durvalumab and Tremelimumab Data - MediPaper Medical Communications

ASCO16 Avelumab, Durvalumab, and Tremelimumab

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