19:50 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

Syndax's entinostat misses PFS endpoint in Phase III for breast cancer

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) reported that entinostat (SNDX-275) missed the primary endpoint of improving progression-free survival (PFS) in the Phase III E2112 trial to treat breast cancer. The company said the trial will continue as...
17:37 , Oct 26, 2018 |  BC Extra  |  Clinical News

Syndax slides on entinostat PFS miss in breast cancer

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) fell $1.03 (17%) to $5.01 Friday after reporting late Thursday that entinostat missed the primary endpoint of improving progression-free survival in the Phase III E2112 trial to treat breast cancer. The...
16:57 , Oct 26, 2018 |  BC Week In Review  |  Company News

NICE recommends against abemaciclib for untreated breast cancer

The U.K.'s NICE issued draft guidance recommending against the use of Verzenio abemaciclib from Eli Lilly and Co. (NYSE:LLY) in combination with an aromatase inhibitor for untreated advanced hormone-receptor positive, HER2-negative breast cancer. NICE said...
02:58 , Sep 1, 2018 |  BioCentury  |  Politics, Policy & Law

Stepping Through

Once considered obstacles to biomedical product development, regulators around the world have become enablers of the kinds of scientific and economic innovations that will underpin new business models. They are building gateways that could help...
18:56 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
21:36 , Aug 23, 2018 |  BC Extra  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
20:49 , Jul 18, 2018 |  BC Extra  |  Company News

FDA real-time pilot speeds Kisqali label expansion

FDA announced on Wednesday that it approved Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) in combination with an aromatase inhibitor for breast cancer in premenopausal and perimenopausal women in the first-line setting, five months ahead...
16:44 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Novartis' Kisqali combo meets PFS endpoint in Phase III for breast cancer in postmenopausal women

Novartis AG (NYSE:NVS; SIX:NOVN) reported data from the Phase III MONALEESA-3 trial to treat breast cancer showing that Kisqali ribociclib in combination with Faslodex fulvestrant met the primary endpoint of improving median progression-free survival (PFS)...
18:04 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Pfizer's Ibrance fails to improve OS in Phase III for breast cancer

Pfizer Inc. (NYSE:PFE) said Ibrance palbociclib plus Faslodex fulvestrant failed to significantly improve overall survival (OS), a secondary endpoint, vs. placebo plus Faslodex in the Phase III PALOMA-3 trial to treat hormone receptor-positive, HER2-negative metastatic...
15:14 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

Roche scraps taselisib plans based on ASCO data

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said they will not seek approval for taselisib after the Phase III SANDPIPER study to treat metastatic breast cancer showed that the molecule provided limited benefit. However,...