Ceritinib

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Retrieved on: 
Tuesday, March 9, 2021

The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

Key Points: 
  • The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
  • "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy.
  • The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) and LORBRENA (lorlatinib).
  • It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) or LORBRENA (lorlatinib) in the US.

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Retrieved on: 
Tuesday, March 9, 2021

The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

Key Points: 
  • The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
  • "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy.
  • The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) and LORBRENA (lorlatinib).
  • It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) or LORBRENA (lorlatinib) in the US.

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

Retrieved on: 
Thursday, March 4, 2021

LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Key Points: 
  • LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
  • AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively.
  • Based on the CROWN data, the FDA has also converted the accelerated approval to full approval.
  • LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, September 8, 2020

It is now also the first and only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.

Key Points: 
  • It is now also the first and only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
  • Thermo Fisher will update the Oncomine Dx Target Test to enable it to report RET fusions in the U.S. before the end of the year.
  • GAVRETO is a potent and selective once-daily oral therapy designed to target RET fusions and mutations.
  • GAVRETO was granted accelerated approval by the FDA on Sept. 4 for the treatment of adult patients with metastatic RET fusion-positive NSCLC.

Incyte Announces FDA Approval of Tabrecta™ (capmatinib) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with METex14

Retrieved on: 
Wednesday, May 6, 2020

Tabrecta, the first and only treatment approved to specifically target NSCLC with this driver mutation, is approved for first-line and previously treated patients regardless of prior treatment type.

Key Points: 
  • Tabrecta, the first and only treatment approved to specifically target NSCLC with this driver mutation, is approved for first-line and previously treated patients regardless of prior treatment type.
  • Novartis has exclusive worldwide development and commercialization rights to Tabrecta, and the FDA approval of Tabrecta triggers $70 million in milestone payments from Novartis to Incyte.
  • We are pleased that the FDA has approved Tabrecta for patients with METex14 NSCLC, said Steven Stein, M.D., Chief Medical Officer, Incyte.
  • Having a therapy that targets the recognized oncogenic driver will provide a much needed treatment option for patients with METex14 NSCLC who currently have limited treatment options.

European Commission Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ NSCLC

Retrieved on: 
Monday, April 6, 2020

ALUNBRIG received Breakthrough Therapy Designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib and was granted Orphan Drug Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC.

Key Points: 
  • ALUNBRIG received Breakthrough Therapy Designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib and was granted Orphan Drug Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC.
  • Phase 2 J-ALTA, single-arm, multicenter trial in Japanese patients with ALK+ NSCLC, focusing on patients who have progressed on alectinib.
  • Phase 2 ALTA 2, global, single-arm trial evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have progressed on alectinib or ceritinib.
  • Phase 3 ALTA 3, global randomized trial comparing the efficacy and safety of ALUNBRIG versus alectinib in participants with ALK+ NSCLC who have progressed on crizotinib.

Takeda Receives Positive CHMP Opinion for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Non-Small Cell Lung Cancer

Retrieved on: 
Monday, March 2, 2020

ALK+ NSCLC is a rarer form of lung cancer, and the needs of people impacted by it are multiple, said Stefania Vallone, President of Lung Cancer Europe (LuCE).

Key Points: 
  • ALK+ NSCLC is a rarer form of lung cancer, and the needs of people impacted by it are multiple, said Stefania Vallone, President of Lung Cancer Europe (LuCE).
  • The positive opinion for ALUNBRIG will now be reviewed by the European Commission (EC) for Commission Decision.
  • Phase 2 ALTA 2, global, single-arm trial evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have progressed on alectinib or ceritinib.
  • Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG.

Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG® (brigatinib) as a First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 24, 2020

In April 2017, ALUNBRIG received Accelerated Approval from the U.S. FDA for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib.

Key Points: 
  • In April 2017, ALUNBRIG received Accelerated Approval from the U.S. FDA for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib.
  • Phase 2 J-ALTA, single-arm, multicenter trial in Japanese patients with ALK+ NSCLC, focusing on patients who have progressed on alectinib.
  • Phase 2 ALTA 2, global, single-arm trial evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have progressed on alectinib or ceritinib.
  • Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG.

Zykadia (Ceritinib; Novartis) Drug Report 2017-2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 4, 2019

Table 3: Zykadia sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017-26

Key Points: 
  • Table 3: Zykadia sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017-26
    Table 4: Zykadia patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26
    View source version on businesswire.com: https://www.businesswire.com/news/home/20190704005081/en/

Cyramza (ramucirumab; Eli Lilly/Shire) Drug Profile - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 20, 2019

Xalkori sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26

Key Points: 
  • Xalkori sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26
    Zykadia sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26
    Capmatinib sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26
    Vargatef patient numbers for NSCLC across the five major EU markets, by country, 2017-26
    Cyramza sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017-26
    Cyramza sales for gastric cancer across the US, Japan, and five major EU markets, by country ($m), 2017-26
    Cyramza patient numbers for gastric cancer across the US, Japan, and five major EU markets, by country, 2017-26
    Cyramza sales for colorectal cancer across the US, Japan, and five major EU markets, by country ($m), 2016-25
    Patients treated with Cyramza across the US, Japan, and five major EU markets, by country, 2016-25
    Zykadia patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017-26
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  • View source version on businesswire.com: https://www.businesswire.com/news/home/20190620005294/en/