Vitrakvi® (larotrectinib)

Updated Vitrakvi® (larotrectinib) Sub-Analysis at ATA 2021 Supports Efficacy and Safety in Adult and Pediatric TRK Fusion Thyroid Cancer Patients

Retrieved on:

Monday, October 4, 2021

Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Vitrakvi® (larotrectinib), TRK Fusion Cancer, Oncology at Bayer, Bayer, VITRAKVI® (LAROTRECTINIB), TRK FUSION CANCER, ONCOLOGY AT BAYER, BAYER

Updated thyroid sub-analysis of 29 adult and pediatric TRK fusion cancer patients, of which 28 were evaluable, treated with Vitrakvi (larotrectinib) showed notable overall response rates (ORR) and duration of response (DoR).

Key Points:

Updated thyroid sub-analysis of 29 adult and pediatric TRK fusion cancer patients, of which 28 were evaluable, treated with Vitrakvi (larotrectinib) showed notable overall response rates (ORR) and duration of response (DoR).
These data in patients with thyroid cancer further underscore the importance of integrating biomarker-driven oncology medicines into cancer care, so that appropriate patients can potentially benefit from a targeted treatment approach.
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein.
These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer.

Latest Analyses of Vitrakvi® (larotrectinib) Support Consistently Meaningful Clinical Profile for Both Adult and Pediatric Patients with TRK Fusion Cancer

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Thursday, September 16, 2021

Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Vitrakvi® (larotrectinib), TRK Fusion Cancer, Oncology at Bayer, Bayer, VITRAKVI® (LAROTRECTINIB), TRK FUSION CANCER, ONCOLOGY AT BAYER, BAYER

The long-term data for Vitrakvi continue to support consistent responses and similar safety profile seen with the addition of new patients and with longer follow-up.

Key Points:

The long-term data for Vitrakvi continue to support consistent responses and similar safety profile seen with the addition of new patients and with longer follow-up.
In patients who received Vitrakvi following one line of systemic therapy (n=59), the ORR was 73% (95% CI 6084).
TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein.
These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer.

Bayer to Highlight Expanded Research from Growing Oncology Portfolio at ESMO Congress 2021

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Thursday, September 9, 2021

Bayer will present new investigational data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.

Key Points:

Bayer will present new investigational data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.
The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.
BAYER, the Bayer Cross, Vitrakvi, NUBEQA, Xofigo, Aliqopa and Stivarga are registered trademarks of Bayer.

Long-term Data on Vitrakvi® (larotrectinib) Further Demonstrate Strong Clinical Profile in Patients with TRK Fusion Cancer Regardless of Tumor Type and Age

Retrieved on:

Wednesday, May 19, 2021

In addition, an intra-patient pooled retrospective analysis assessing the treatment effect of Vitrakvi in patients with TRK fusion cancer previously treated with one or more line of therapy were presented.

Key Points:

In addition, an intra-patient pooled retrospective analysis assessing the treatment effect of Vitrakvi in patients with TRK fusion cancer previously treated with one or more line of therapy were presented.
Two percent of patients discontinued Vitrakvi due to TRAEs and no treatment-related deaths were reported.\nData for the integrated dataset were pooled from three Vitrakvi clinical trials (NCT02122913, NCT02576431 and NCT02637687) in adult and pediatric patients with TRK fusion cancer.
These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer.
Intra-patient comparison from larotrectinib clinical trials in TRK fusion cancer \xe2\x80\x93 an expanded dataset [abstract].

Bayer Presents Latest Data and New Research to Advance Cancer Care within Oncology Portfolio at 2021 ASCO Annual Meeting

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Tuesday, May 11, 2021

b'Bayer will present new data across its oncology portfolio at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021.

Key Points:

b'Bayer will present new data across its oncology portfolio at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021.
If withheld, modify the VITRAKVI dosage when resumed.\nEmbryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman.
The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development.
These factors include those discussed in Bayer\xe2\x80\x99s public reports which are available on the Bayer website at www.bayer.com .

Bayer to Present New Clinical Data in Indolent non-Hodgkin's Lymphoma and Additional Research on its Oncology Portfolio at AACR Annual Meeting 2021

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Tuesday, April 6, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Companies, Biology, Life sciences, Aspirin, Bayer, IG Farben, Leverkusen, Biomarker, Aliqopa® (copanlisib) Injection, Vitrakvi® (larotrectinib), NUBEQA® (darolutamide), Xofigo® (radium Ra 223 dichloride) Injection, Oncology at Bayer, Bayer

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021.

Key Points:

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021.
The new data reaffirm Bayer's continued efforts to investigate the clinical impact a biomarker-driven approach can have on patients.
Bayer will also reveal the latest data from its differentiated early pipeline across other focus areas, including precision molecular oncology and immuno-oncology.
Overall, these data stress Bayers commitment to continued research in some of the companys key areas of focus in oncology.

FDA Approves FoundationOne®CDx as Companion Diagnostic for Vitrakvi® (larotrectinib), to Aid in Identifying NTRK Fusion-Positive Patients

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Friday, October 23, 2020

Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Drug Safety, Health, Adverse effect, Clinical pharmacology, Medical terminology, Patient safety, Monoclonal antibodies, Vitrakvi® (larotrectinib), TRK Fusion Cancer, Oncology at Bayer, Bayer

The U.S. FDA approval of FoundationOne CDx for Vitrakvi allows patients who may benefit from this treatment to be identified in a more precise way.

Key Points:

The U.S. FDA approval of FoundationOne CDx for Vitrakvi allows patients who may benefit from this treatment to be identified in a more precise way.
Vitrakvi is approved in 42 countries, including the U.S., Canada, Brazil and the European Union (EU).
Neurotoxicity: Among the 176 patients who received VITRAKVI, neurologic adverse reactions of any grade occurred in 53% of patients, including Grade 3 and Grade 4 neurologic adverse reactions in 6% and 0.6% of patients, respectively.
The majority (65%) of neurologic adverse reactions occurred within the first three months of treatment (range 1 day to 2.2 years).

New Data Support Strong Clinical Profile of Vitrakvi® (larotrectinib) for Adult and Pediatric Patients with TRK Fusion Cancer, Including Lung and Thyroid Tumors

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Thursday, September 17, 2020

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer, Clinical medicine, Medicine, Oncology, Larotrectinib, Metástasis, Vitrakvi® (larotrectinib), TRK Fusion Cancer, Oncology at Bayer, Bayer

These data affirm Vitrakvis robust clinical profile with the largest dataset and longest follow-up of any TRK inhibitor and reinforce our longstanding commitment to developing innovative treatments for patients.

Key Points:

These data affirm Vitrakvis robust clinical profile with the largest dataset and longest follow-up of any TRK inhibitor and reinforce our longstanding commitment to developing innovative treatments for patients.
For patients with CNS metastases, the ORR was 57% (95% CI 18-90; no patients with CR, n=4/7 with PRs).
In the analysis of 122 adult and pediatric patients with metastatic and locally advanced disease treated with Vitrakvi, the median GMI was 3.35 (range 0.00-337).
Growth modulation index (GMI) of larotrectinib versus prior systemic treatments for TRK fusion cancer patients.

The Efficacy of Vitrakvi® (larotrectinib) Further Demonstrated High Response Rates and Duration of Response in an Updated Analysis and New Quality of Life Data to Be Presented at ASCO

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Friday, May 29, 2020

Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical trials, Health, Medical terminology, Bayer AG, Eli Lilly and Company, Larotrectinib, Quality of life, Vitrakvi® (larotrectinib), TRK Fusion Cancer, Oncology at Bayer, Bayer

A separate descriptive analysis evaluated quality of life (QoL) measures for adult and pediatric patients, including infants younger than 2 years, using clinical questionnaires.

Key Points:

A separate descriptive analysis evaluated quality of life (QoL) measures for adult and pediatric patients, including infants younger than 2 years, using clinical questionnaires.
This indication is approved under accelerated approval based on overall response rate and duration of response.
The median duration of response was 35.2 months (95 percent CI 21.6not estimable [NE]) at a median follow-up of 17.4 months.
Quality of life of adults and children with TRK fusion cancer treated with larotrectinib compared to the general population [abstract].

Bayer and ArcherDX Announce Global Collaboration to Develop Next-Generation Sequencing (NGS)-based Companion Diagnostic (CDx) for VITRAKVI® (larotrectinib)

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Thursday, May 14, 2020

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Medicine, CDX, CDX, Companion diagnostic, Embryology, Branches of biology, Fetus, Larotrectinib, Vitrakvi® (larotrectinib), Oncology at Bayer, ArcherDX, Bayer

Bayer and ArcherDX, Inc. today announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi (larotrectinib).

Key Points:

Bayer and ArcherDX, Inc. today announced a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi (larotrectinib).
The collaboration with ArcherDX perfectly complements Bayers CDx strategy and fits our ambition to provide the right treatment to the right patients with cancer.
We are pleased to collaborate with Bayer to address their medical need and accelerate access to therapy.
If withheld, modify the VITRAKVI dosage when resumed.1
Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman.