Alectinib FDA approved for ALK-positive metastatic NSCLC | MediPaper

Non-Sponsored Content

FDA ONCOLOGY & HAEMATOLOGY APPROVALS

Alectinib FDA approved for ALK-positive metastatic NSCLC

By: News Feed | Last updated: 6th November 2017 | In: US FDA Onc\Haem Approvals

Article Keywords

Alecensa, alectinib, ALK, FDA, Genentech, Roche

On 6 November 2017, the FDA granted regular approval to alectinib (Alecensa®, Roche/Genentech) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

© Copyright 2018 MediPaper Medical Communications Ltd.

YOU MAY ALSO LIKE

Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma

Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer

Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer

Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC

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

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

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy

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

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

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

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

Robert Lewandowski Y90 TARE TheraSphere The Emerging Role of Yttrium90 in Primary and Metastatic Liver Cancer hepatocellular carcinoma hcc

The Emerging Role of Yttrium-90 in Primary and Metastatic Liver Cancer

Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis

Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction

Pembrolizumab FDA approved in hepatocellular carcinoma patients pretreated with sorafenib

Lorlatinib FDA approved for metastatic ALK-positive NSCLC

ESMO 2018 HCC ESMO18 Liver Cancer ESMO2018 hepatocellular carcinoma hepatobiliary cholangiocarcinoma BTC

ESMO 2018 HCC: The ESMO18 hepatobiliary cancer track summarised

Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC

Dr Joanne Chiu HKU management irAE hepatitis manage immune-mediated hepatitis immunotherapy I-O immunooncology immune-induced hepatitis

Management of Immune-Mediated Hepatitis: a Case Report

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

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

IMpower133 first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Pembrolizumab plus chemotherapy effective in squamous NSCLC

Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer

Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC

CAR-T axicabtagene ciloleucel granted Orphan Drug Designation for B-Cell Lymphoma by the Japan MHLW

CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC)

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

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

©United States Food and Drug Agency US FDA

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

©United States Food and Drug Agency US FDA

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

Front-line atezolizumab plus chemotherapy improves PFS in NSCLC

Frontline atezolizumab plus chemotherapy improves PFS in NSCLC

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

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

Early breast cancer treatment in China remains conservative

Early breast cancer treatment in China remains conservative

immuno-oncology I-O treatment for the irAE Rash

©MediPaper Medical Communications Ltd

ImmunoOncology: Dr Oscar Chan on the treatment of irAE rash

Prof Stefan Kasper on I-O in EXTREME-ineligible Head and Neck Cancer I-O in SCCHN with focus on EXTREME-ineligible Patients and the future directions of combination immunotherapy

Prof Stefan Kasper on I-O in EXTREME-ineligible SCCHN

Camrelizumab anti-PD-1 with or without Chemotherapy for NPC

Camrelizumab anti-PD-1 with or without chemotherapy for NPC

©United States Food and Drug Agency US FDA

Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia

Adrian TSE HKIOC irAE pneumonitis lung immunotherapy-induced pneumonitis I-O Immuno-Oncology cannonball metastases cancer

©MediPaper Medical Communications Ltd

I-O in Special Populations: the Treatment of Immunotherapy-Induced Pneumonitis

©United States Food and Drug Agency US FDA

Venetoclax FDA label updated to include Minimal Residual Disease negativity data

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

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

Lung Cancer Capmatinib plus gefitinib promising in MET-dysregulated NSCLC MediPaper Medical Communications Medical Writer Hong Kong 醫學寫作醫學作家香港

© Eraxion / 123RF Stock Photo

Capmatinib plus gefitinib promising in MET-dysregulated NSCLC

CAR-TCR Summit 2018 Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer

© Royaltystockphoto / 123RF Stock Photo

CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer

DRIVER connects cancer patients in China and the United States to the best care

© Kentoh / 123RF Stock Photo

DRIVER connects cancer patients in China and the United States to the best care

Blood-based TMB-assay predicts response to atezolizumab in NSCLC patients

Plasma TMB predicts response to atezolizumab in NSCLC patients

First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

© luchschen / 123RF Stock Photo

First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

Pembrolizumab and atezolizumab USPIs updated by FDA

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

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

Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous 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

CheckMate 032 Nivolumab ipilimumab metastatic esophagogastric cancer

CheckMate 032: Nivolumab +/- ipilimumab for metastatic esophagogastric cancer

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

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

©Alex011973 / 123RF Stock Photo

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

FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information. July 31, 2018.

FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL

FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information. July 31, 2018.

Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours

T790M osimertinib nsclc brain metastasis CNS metastases Osimertinib in patients With T790M-Positive Advanced Non-Small-Cell Lung Cancer and brain metastases AURA3

© srr283/123RF

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

Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

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

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Ribociclib FDA label updated to include pre- and perimenopausal women

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

Enzalutamide FDA approved for castration-resistant prostate cancer (CRPC)

EBV pembrolizumab gastric cancer - MSI-H pembrolizumab gastric cancer - CPS pembrolizumab gastric cancer - MSI, EBV, CPS predict pembrolizumab outcome in gastric cancer

© abhijith3747/123RF

EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

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

ASCO 2018 nsclc immunotherapy ASCO18 lung cancer pembrolizumab avelumab nivolumab duravalumab ipilimumab osimertinib dacomitinib lorlatinib crizotinib alectinib keytruda KEYNOTE CheckMate JAVELIN IMpower

©eraxion / 123RF Stock Photo

ASCO 2018 NSCLC: The ASCO18 Lung Cancer Track Summarised

FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. More Information. June 19, 2018

FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

ASCO 2018 breast cancer TNBC MBC ABC ASCO18 PHEREXA D-CARE ABCSG-18 ASTRRA TEXT SOFT MONARCH-2 MONALEESA-3 SANDPIPER BOLERO-6 TOPACIO KEYNOTE-162 TONIC TOPACIO GeparNeuvo

©eraxion / 123RF Stock Photo

ASCO 2018 Breast Cancer: The ASCO18 breast cancer track summarised

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

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

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1

ASCO18 ASCO 2018 HCC hepatocellular carcinoma liver cancer pembrolizumab KEYTRUDA atezolizumab TECENTRIQ PD-1 PD-L1 immunecheckpoint immunotherapy ramucirumab cabozantinib KEYNOTE-224 SCRUM-Japan GI-SCREEN CELESTIAL REACH-2

© krishnacreations / 123RF Stock Photo

ASCO 2018 HCC: The ASCO18 hepatocellular cancer track summarised

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

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

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

IMPower150 Reck Socinski ELCC AACR 2018 firstline atezolizumab bevacizumab chemotherapy non-squamous nsclc

bravajulia / 123RF Stock Photo

AACR 2018: first-line atezolizumab, bevacizumab plus chemotherapy active in non-squamous NSCLC

US FDA approved CAR-t cell BiTE DAR-T cell CD19 Immunotherapies blinatumomab axicabtagene ciloleucel tisagenlecleucel

US FDA approved CAR-T cell and BiTE immunotherapy - Updated 2-May-2018

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma

AACR 2018 First-line Nivolumab-Ipilimumab in TMB-high NSCLC front-line immunotherapy for non-small cell lung cancer tumour-mutation burden CheckMate 227 NCT02477826

Hywards / 123RF Stock Photo

Nivolumab-Ipilimumab Combination: A New Option for TMB-High NSCLC (CheckMate 227)

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

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)

NCT02578680 Keynote189 AACR 2018 pembrolizumab chemotherapy nsclc NEJM Leena Gandhi

krishnacreations / 123RF Stock Photo

Frontline Combination of Pembrolizumab and Chemotherapy: A New Standard of Care for Non-squamous NSCLC

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Frontline nivolumab plus ipilimumab approved for intermediate or poor risk advanced RCC

Keynote-042 Keynote-024 pembrolizumab nsclc keytruda nsclc non-squamous squamous PD-L1 expression 1% 20% 50% Tony Mok MD NCT02220894 Pembrolizumab effective in frontline NSCLC with low PD-L1 expression

Pembrolizumab effective in frontline NSCLC with low PD-L1 expression

Ribociclib FDA label updated to include pre- and perimenopausal women

©United States Food and Drug Agency

Everolimus suspension approved in TSC-associated partial-onset seizures

Herbert Loong on irAEs Immunotherapy (I-O) and New Onset Diabetes or immune-mediated diabetes

I-O in Special Populations: Diabetes and Concomitant Steroids

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

Death due to cancer on the decline for most tumours in Europe

immunotherapy I-O immunooncology nivolumab npc opdivo nasopharyngeal carcinoma brigette ma CUHK phase II nci-9742 study JCO journal of clinical oncology

Nivolumab for NPC: immunotherapy active in nasopharyngeal carcinoma (NCI-9742)

©aquir / 123RF Stock Photo

FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%

Making sense of immunotherapy in NSCLC

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

Symposium Highlight 5HT3 NK1 Palonosetron Netupitant CINV Chemotherapy-induced Nausea and Vomiting

Advances in the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting: From Multi-Dose to Single Dose Control

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

2016 pancreatic cancer awareness month IMM-101 plus Gemcitabine medipaper medical communications medical writer hire healthcare writers hong kong

Do you know your lifetime risk on Pancreatic Cancer?

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?

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

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

Nivolumab approved for sorafenib-refractory HCC

Nivolumab Renal Cell Cancer Symposium Highlight

Nivolumab for Renal Carcinoma: Getting the Most Out of PD-1 Immunotherapy

adjuvant hormonal therapy

Should all Women with Endocrine-Sensitive and Operable Breast Cancer Receive Adjuvant Hormonal Therapy?

2017 CICS immunooncology annual meeting oncology medical writer medipaper medical communications

Interested in Attending an Immunooncology Conference?

esmo 2016 breast cancer ribociclib palbociclib abemaciclib data medipaper medicall writer

ESMO16 Breast Cancer: Palbociclib, Ribociclib and Abemaciclib Data

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

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

Biomarkers Ipilimumab Treatment MediPaper Medical Communications

Novel Biomarker for Ipilimumab Treatment may aid Future Patient Selection in Several Malignancies

ESMO 2016 ipilimumab data medipaper medical communications

ESMO16 Ipilimumab data - Download the PPT

ESMO 2016 pembrolizumab data medipaper medical communications

ESMO16 Pembrolizumab data - Download the PPT

ESMO 2016 durvalumab avelumab tremelimumab data medipaper medical communications

ESMO16 Durvalumab, Avelumab, Tremelimumab Data - Download the PPT

ESMO 2016 atezolizumab data medipaper medical communications

ESMO16 Atezolizumab data - Download the PPT

ESMO 2016 nivolumab data medipaper medical communications

ESMO16 Nivolumab data - Download the PPT

cancer awareness improves outcome medipaper medical communications

Cancer symptom awareness linked to survival

2016 ASCO ovarian cancer guidelines neo-adjuvant chemotherapy medipaper medical communications

ASCO Guideline NeoAdjuvant Chemotherapy for Ovarian Cancer Updated

IMM-101 plus gemcitabine-medipaper medical communications BW

IMM101 plus Gemcitabine Hopeful in Metastatic Pancreatic Cancer

palbociclib-first-in-class

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

Ki67 breast cancer medical writer epotomics

Ki67 in Breast Cancer: an overview

ASCO 2016 ribociclib & abemaciclib Data - MediPaper Medical Communications

ASCO16 Ribociclib & Abemaciclib Data

ASCO 2016 Palbociclib Data MediPaper Medical Communications

ASCO16 palbociclib (Ibrance©) Data

ASCO 2016 Avelumab Durvalumab and Tremelimumab Data - MediPaper Medical Communications

ASCO16 Avelumab, Durvalumab, and Tremelimumab

asco 2016 atezolizumab data

ASCO16 Atezolizumab (Tecentriq©) Data

ASCO2016 ipilimumab data - MediPaper Medical Communications

ASCO16 Ipilimumab (Yervoy©) Data

asco 2016 nivolumab medipaper medical communications

ASCO16 Nivolumab (Opdivo©) Data

asco 2016 pembrolizumab medipaper medical communications

ASCO16 Pembrolizumab (Keytruda©) Data

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply Cancel reply

You must be logged in to post a comment.

© Copyright 2018 MediPaper Medical Communications Ltd.

Therapeutic Areas