Sun Pharm`s Generic Afatinib Receives Tentative Approval In US
TOKYO & MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)-- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) presented updated phase 1 data for patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), including the first results from one cohort of the dose expansion part of the study in patients with epidermal growth factor receptor (EGFR)-mutated metastatic or unresectable non-small cell lung cancer (NSCLC) after failing treatment with a tyrosine kinase inhibitor (TKI). The late-breaking data (Abstract #LBA62) were highlighted during a mini-oral presentation today at the European Society of Medical Oncology Virtual Congress 2020 (#ESMO20).
Boehringer Ingelheim today announced the launch of a patient outcomes database which will provide clinicians with important information when considering optimal treatment for non-small cell lung cancer (NSCLC) patients harboring specific uncommon epidermal growth factor receptor (EGFR) mutations. The real-world database includes all available data from such patients treated with afatinib.
Johnson and Johnson has been awarded a breakthrough designation from the FDA for a bispecific antibody for lung cancer that combines MET and EGFR targeting in the same molecule.
German firm Boehringer Ingelheim has released new interim data from a real-world evidence study investigating the efficacy of Giotrif/Gilotrif (afatinib) followed by AstraZeneca’s Tagrisso (osimertinib) in the treatment of epidermal growth factor receptor mutation-positive (EGFRM+) non-small cell lung cancer (NSCLC) in patients with acquired T790M mutations.
England’s cost watchdogs won’t get behind AstraZeneca blockbuster Tagrisso in previously untreated patients with EGFR-mutated lung cancer. But in a change of events, they’re instead backing a Pfizer challenger.
The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling.
China's State Medical Insurance Administration announced 18 cancer drugs that will be included in 2018 medical insurance access negotiations. Companies with drugs on the list will now enter into negotiations to include the drugs on the country's National Reimbursement Drug List (NRDL).
GILOTRIF® (afatinib): Boehringer Ingelheim Pharmaceuticals, Inc. et al v. Apotex Inc. et al
In mice, two Austrian teams led by Herwig Moll and Björn Kruspig from Medical University Vienna showed independently that the growth of an intractable type of lung cancer that carries mutations in the K-RAS gene can be restrained by EGFR blockade. Kruspig et al demonstrated that deletion of the Egfr gene quenched mutant K-RAS activity and transiently reduced tumor growth. Moll and colleagues found that activation of the EGFR pathway promotes growth of KRAS-positive tumours and could be blocked with afatinib in mice.