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US FDA approved immune-checkpoint inhibitors updated 09-Mar-2019

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.

Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients

On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.

Lorlatinib FDA approved for metastatic ALK-positive NSCLC

On November 2nd 2018, lorlatinib (LORBRENA®, Pfizer) received accelerated approval by the FDA for the second- and third-line treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). Third-line patients should have had progression on crizotinib and another ALK-inhibitor for metastatic disease, and second-line patients should have had progression on either alectinib or ceritinib in the first-line for metastatic disease.

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.

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib (Alunbrig®, Ariad) significantly prolongs the progression-free survival (PFS) in anaplastic lymphoma kinase (ALK) inhibitor-naïve patients with ALK-rearranged non-small cell lung cancer (NSCLC) when compared to crizotinib, as resulted from the ALTA-1L study.

JAVELIN Lung 200 avelumab vs docetaxel in patients with pretreated advanced non-small cell lung cancer NSCLC

JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC

Avelumab (Bavencio®, Merck KGaA) does not improve the overall survival (OS) in non-small cell lung cancer (NSCLC) patients previously treated with platinum-doublet chemotherapy, as resulted from the JAVELIN Lung 200 study (NCT02395172). The safety profile favoured avelumab over docetaxel.

Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC

On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.

Talazoparib in advanced breast cancer patients with a germline BRCA1:2 mutation

Talazoparib in advanced breast cancer patients with a germline BRCA1/2 mutation

Single-agent PARP-inhibition with talazoparib is associated with an improved progression-free survival (PFS) and better patient-reported outcomes (PRO) when compared to chemotherapy alone in patients with advanced breast cancer (ABC) and a germline BRCA1/2 mutation, as reported by the investigators of the Phase III EMBRACA study (NCT01945775) in the New England Journal of Medicine.

FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

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.

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.

Biosimilar epoetin alfa-epbx approved by FDA for the treatment of anemia due to chronic kidney disease, use of zidovudine for HIV, and concomitant myelosuppressive chemotherapy

 

Bosutinib FDA approved for the treatment of patients with newly-diagnosed chronic phase Ph+ CML

On 19 December 2017, the FDA granted accelerated approval to bosutinib (Bosulif®, Pfizer) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML).

manuela schmidinger sutent sunitinib ae management manuela schmidinger manuela schmidinger sutent sunitinib side-effect management sutent sunitinib toxicity management Sutent Sunitinib AE management toxicity management side-effect management sorafenib pazopanib axitinib regorafenib vandetanib cabozantinib lenvatinib bevacizumab VEGFR VEGF renal cell carcinoma RCC kidney cancer renal cell cancer schmidinger

Achieving Long-Term Survival in the First-Line Treatment of Metastatic Renal Cell Carcinoma; A Balancing Act of Efficacy and Side-Effects

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Adjuvant sunitinib FDA approved for renal cell carcinoma patients at high risk of recurrence following nephrectomy.

On 16 November 2017, the FDA approved sunitinib malate (Sutent®, Pfizer) for the adjuvant treatment of adult renal cell carcinoma patients at high risk of recurrence following nephrectomy.

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.

esmo 2016 breast cancer ribociclib palbociclib abemaciclib data medipaper medicall writer

ESMO16 Breast Cancer: Palbociclib, Ribociclib and Abemaciclib Data

Cyclin-dependent Kinase 4 and 6 (CDK4/6) inhibitors have shown clinical activity in patients with endocrine-resistant metastatic breast cancer. During the European Society for Medical Oncology (ESMO) Annual Meeting 2016, significant updates on studies with CDK4/6 inhibitors ribociclib, palbociclib and abemaciclib were presented.

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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palbociclib-first-in-class

Palbociclib (Ibrance®): First in Class CDK4/6 Inhibitor

At the American Association for Cancer Research, 2014 annual meeting (AACR) Richard Finn presented the results of the PALOMA-1 study with Ibrance® (palbociclib), an oral inhibitor of cyclin-dependent kinase 4/6 (CDK4/6). Based on the results of this Phase 2 study, palbociclib was recently approved by the United States Drug and Food Administration (U.S. FDA). What is the current level of evidence on palbociclib in approved indications?

Ki67 breast cancer medical writer epotomics

Ki67 in Breast Cancer: an overview

Recent studies have shown new possible applications for Ki67. Huh et al. showed that low Ki67 levels in healthy breast tissue correlated with a lesser lifetime chance of breast cancer. Another study by Arnedos and colleagues concluded that palbociclib was able to invoke a significant Ki67-level drop. After a decade of Ki67-controversies, these results put the marker back in the spotlight.

ASCO 2016 Palbociclib Data MediPaper Medical Communications

ASCO16 palbociclib (Ibrance©) Data

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ASCO 2016 Avelumab Durvalumab and Tremelimumab Data - MediPaper Medical Communications

ASCO16 Avelumab, Durvalumab, and Tremelimumab

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