The FDA on Friday approved AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2-positive solid tumors in adults who have undergone prior systemic treatment and have no alternative treatment options.
Tag Archive for: Enhertu
The Japanese pharma now expects the AstraZeneca-partnered Enhertu to bring in approximately $2.61 billion for the fiscal year 2023, this time driven by growth outside the United States.
In its final decision, the U.S. PTO invalidated all of the claims in Seagen’s patent 10,808,039, which covers the use of auristatin peptides connected to antibody-drug conjugates (ADCs) via a specific linker technology.
For AstraZeneca, the approval of Enhertu last year marked one of the high points in the company’s scientific program.
BioNTech’s licensed antibody-drug conjugate is moving on to Phase III testing in a potential effort to challenge AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu in a heavily treated breast cancer subpopulation. DualityBio, BioNTech’s partner and the ADC’s creator, posted the trial plans Wednesday.
AstraZeneca said on Monday a mid-stage trial of its cancer drug Enhertu showed positive results across multiple HER2-expressing advanced solid tumors in heavily pre-treated patients.
Gilead Sciences Inc. said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common type of breast cancer, marking the third approval for the drug.
The rush to use AstraZeneca and Daiichi-Sankyo’s drug Enhertu to treat certain types of breast cancer has far outpaced doctors’ ability to determine with certainty which patients might benefit, experts said this week at a meeting of breast cancer doctors.
Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.
The U.S. Food and Drug Administration’s (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical’s experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.
