20:53 , May 17, 2019 |  BC Extra  |  Clinical News

AbbVie's antibody-drug conjugate misses mark in Phase III GBM trial

In a second setback for glioblastoma multiforme patients this month, AbbVie said its depatuxizumab mafodotin missed the primary endpoint of improving overall survival in the Phase III INTELLANCE-1 for newly diagnosed EGFR-amplified GBM. AbbVie Inc....
13:26 , May 17, 2019 |  BioCentury  |  Product Development

Takeda shaves years off PRO development, brings patient voice to fatigue measures in cancer

Takeda has sidestepped the FDA qualification process for patient-reported outcomes by building on validated tools to develop a PRO for fatigue in hematologic malignancies. The approach enabled the pharma to cut its PRO development time...
23:10 , May 16, 2019 |  BC Extra  |  Clinical News

Roche, Bayer unveil brain tumor data for NTRK inhibitors ahead of ASCO

Efficacy data for two tissue-agnostic NTRK inhibitors from Roche and Bayer to treat primary and metastatic brain tumors were released in abstracts ahead of the American Society of Clinical Oncology meeting in Chicago. Data from...
22:33 , May 16, 2019 |  BC Extra  |  Politics & Policy

FDA to launch program to facilitate expanded access at ASCO meeting

FDA will announce at the upcoming ASCO meeting the launch of Project Facilitate, a concierge service to help guide physicians through the process of applying for expanded access, also called compassionate use access. Speaking Thursday...
21:36 , May 16, 2019 |  BC Extra  |  Clinical News

May 16 ASCO Quick Takes: Aduro ends MM trial; plus Puma, PharmaMar, Genocea, J&J

Abstracts were released late Wednesday ahead of the American Society of Clinical Oncology meeting starting May 31 in Chicago. See below for BioCentury's second round of Quick Takes on selected abstracts (see "May 15 ASCO...
00:06 , May 16, 2019 |  BC Extra  |  Clinical News

May 15 ASCO Quick Takes: After-hours pop for Iovance, MacroGenics; plus Takeda, Amgen, Forty Seven

Abstracts were released late Wednesday ahead of the American Society of Clinical Oncology meeting starting May 31 in Chicago. See below for BioCentury's first round of Quick Takes on selected abstracts. Iovance gains on 44%...
21:34 , May 3, 2019 |  BC Week In Review  |  Clinical News

Keytruda monotherapy non-inferior to chemotherapy in first-line gastric cancer

Merck said April 25 that Keytruda pembrolizumab as monotherapy met the primary endpoint of non-inferiority to standard-of-care chemotherapy in improving overall survival (OS) in the Phase III KEYNOTE-062 trial as first-line treatment of gastric cancer....
23:08 , May 1, 2019 |  BC Extra  |  Company News

Caris aims to bridge gap between patients, precision trials with Pharmatech takeout

Caris' acquisition of Pharmatech, announced Wednesday, will allow the molecular profiling company to offer patients, physicians and drug developers an integrated approach to identifying and enrolling patients with rare mutations and other biomarkers in precision...
22:34 , May 1, 2019 |  BC Extra  |  Politics & Policy

CMS to reexamine coverage of germline sequencing tests

CMS said it will reopen its analysis of the National Coverage Determination for next-generation sequencing tests for cancer patients. The agency is only reconsidering evidence for tests of germline mutations to identify those with hereditary...
23:17 , Apr 26, 2019 |  BC Extra  |  Clinical News

Patient access pitfalls, regulatory inconsistencies hamper tissue agnostic drugs

At a Friday meeting FDA co-hosted with ASCO and Friends of Cancer Research, patient advocates expressed concern over their ability to access newly approved tissue-agnostic medicines, as well as clinical trials assessing up-and-coming treatments based...