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MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.

Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations

On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).

TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion

On 26 November 2018, the FDA granted accelerated approval to the first-in-class tropomyosin receptor-kinase (TRK) inhibitor larotrectinib (Vitrakvi®, Loxo Oncology/Bayer) for the treatment of adult and paediatric patients with solid tumours that are metastatic or not amenable to surgery, harbour the neurotrophic receptor tyrosine kinase (NTRK) gene fusion in the absence of known acquired resistance mutations, and whose cancer progressed following treatment or for whom are no satisfactory other treatment options available.

Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients

On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.

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.

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ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised

Whereas this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2018) boasted two Phase III studies and four Phase II studies with notable results in hepatocellular carcinoma (HCC), the trend did not continue to the European Society for Medical Oncology Conference (ESMO 2018), held in Münich, Germany between October 19-23, 2018. The focus for this years ESMO was mostly on biliary-tract cancers (BTC). Welcome to the hepatobiliary track of ESMO 2018.

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.

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.

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.

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.

Duvelisib FDA approved for adult patients with R/R CLL or SLL

On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.

Duvelisib FDA approved for adult patients with R/R follicular lymphoma

On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.

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).

Venetoclax FDA label updated to include Minimal Residual Disease negativity data

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.

Quizartinib Receives Orphan Drug Designation for FLT3-Mutated AML in Japan

Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan

TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018  — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.

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).

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.

Pembrolizumab plus pemetrexed-platinum approved for use in the 1st-line treatment of metastatic non-squamous NSCLC

Lenvatinib FDA approved for 1st-line treatment of HCC

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.

Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China

HONG KONG, CHINA – 13 August 2018 – Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States. 

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.

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.

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.

Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved

On June 27th, the FDA approved Array Biomarpharma’s combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.

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.

Bevacizumab in combination with carboplatin and paclitaxel FDA approved for several types of gynaecological cancers

 

ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised

This year’s American Society of Clinical Oncology (ASCO) annual meeting includes two Phase III studies in the second-line treatment of the disease. Moreover, data with several immune-checkpoint inhibitors were presented, including the KEYNOTE-224 with pembrolizumab. Welcome to the summary of the ASCO 2018 HCC track.

FDA approves venetoclax in 2nd-line for patients with CLL or SLL

 

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.

Crizotinib beneficial for East-Asian NSCLC-patients with ROS1 alterations crizotinib asian crizotinib ros1 crizotinib asian nsclc patients crizotinib asian non-small cell lung cancer patients

Crizotinib beneficial for East-Asian NSCLC patients with ROS1 alterations

Crizotinib in Asian NSCLC patients with ROS1 alterations was associated with a 71.7% objective response rate (ORR) with a median duration of response (DOR) of 19.7 months (95% CI, 14.1 months – not reached). Learn more about the results with crizotinib in East-Asian non-small cell lung cancer (NSCLC) patients harbouring c-ros oncogene 1 (ROS1) rearrangements.

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Nivolumab approved for sorafenib-refractory HCC

On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval was based on a 154-patient subgroup of CHECKMATE-040 (NCT 01658878), a multicenter, open-label trial conducted in patients with HCC and […]

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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 ribociclib & abemaciclib Data - MediPaper Medical Communications

ASCO16 Ribociclib & Abemaciclib Data

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ASCO 2016 Palbociclib Data MediPaper Medical Communications

ASCO16 palbociclib (Ibrance©) Data

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