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FDA grants Breakthrough designation for BI 1482694 in lung cancer


FDA Grants BI-1482694 Breakthrough Designation for T790M ...

“These data further validate BI-1482694 as a potential treatment for lung cancer patients who encounter resistance to first- or second-generation EGFR ...

FDA grants breakthrough therapy designation to BI 1482694 for ...

... lung cancer who have T790M mutations, according to a press release from the drug's manufacturer.BI 1482694 (Boehringer Ingelheim) is a third ...

FDA grants Breakthrough designation for BI 1482694 in lung cancer

The first pivotal Phase II trial (ELUXA 1/HM-EMSI-202) is designed to further investigate the efficacy and safety of BI 1482694 in patients with ...

FDA Grants Breakthrough Therapy Designation to - ProQuest

FDA Grants Breakthrough Therapy Designation to Investigational Lung Cancer Treatment ... BI 1482694 (HM61713). ... BI 1482694. We feel this designation reflects the ...

Boehringer Ingelheim Receives FDA Breakthrough Therapy ...

The pivotal clinical development programme of BI 1482694 in lung cancer, ELUXA, encompasses multiple trials including Phase III studies starting ...

Boehringer Ingelheim receives FDA Breakthrough Therapy ...

FDA designation reinforces potential for BI 1482694 to become a new treatment option for patients with EGFR mutation-positive lung cancer with a T790M ...

FDA Awards Breakthrough Therapy Designation to Boehringer's ...

BI 1482694 is a third-generation EGF mutant-specific tyrosine kinase inhibitor that has demonstrated strong anti-tumor activity and a ...

Boehringer Ingelheim's third generation EGFR TKI, BI 1482694 ...

"Boehringer Ingelheim is pleased that the FDA has granted Breakthrough Therapy Designation to our investigational third-generation EGFR inhibitor BI 1482694. We ...

FDA grants breakthrough therapy designation to BI-1482694 for ...

Upgrade your daily dose of biopharma and medtech news · FDA grants breakthrough therapy designation to BI-1482694 for EGFR-mutant NSCLC · Popular Stories · Today's ...

Breakthrough Therapy Designation Highlights Cancer News Review

The FDA has granted a breakthrough therapy designation to the third-generation EGFR TKI BI-1482694 as a potential treatment for patients with T790M-positive ...

FDA Breakthrough Therapy Status to Third-Generation TKI, BI

The designation is based on results from the Phase I/II HM-EMSI-101 clinical trial evaluating the treatment of T790M mutation-positive NSCLC in ...

BI-1482694 Granted Breakthrough Status in T790M-Positive NSCLC ...

The FDA has assigned a breakthrough therapy status to the third-generation EGFR TKI BI-1482694 as a possible treatment for patients with ...

Breakthrough Therapy Granted to Boehringer Ingelheim TKI Inhibitor ...

FDA granted Breakthrough Therapy Designation to an epidermal growth factor receptor mutant-specific tyrosine kinase inhibitor, BI 1482694 ...

FDA Grants Breakthrough Therapy Designation to Drug Targeting ...

According to Boehringer Ingelheim, the maker of 1482694, the drug is targeted to NSCLC patients whose tumors have epidermal growth factor (EGFR) ...

BI-1482694 After EGFR TKI Therapy Shows Promise in NSCLC

BI-1482694 received a breakthrough therapy designation from the FDA in December, 2015 for the treatment of patients with NSCLC based on phase I/II data ...

FDA Approves First Targeted Therapy for Subset of Non-Small Cell ...

The FDA approved the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic ...

FDA grants new breakthrough therapy designation to ... - | BioWorld

... breakthrough therapy designation to Tagrisso in NSCLC ... lung cancer (NSCLC). The designation was based on ... FDA grants breakthrough therapy designation to BI- ...

News | Clinical Oncology News & Insights | OncLive | Page 488

FDA Grants BI-1482694 Breakthrough Designation for T790M-Positive NSCLC ... FDA Grants Priority Review to Palbociclib in Pretreated HR+/HER2- Breast Cancer.

FDA Grants Breakthrough Therapy Designation for IPF

FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis · Ridgefield, Conn. and Ingelheim, Germany, February 24, ...

Third-generation epidermal growth factor receptor tyrosine kinase ...

Rociletinib is an oral, targeted covalent (irreversible) mutant-selective EGFR TKI for the treatment of EGFR-mutant (activating and T790M) NSCLC (42) that was ...