01:43 , Jun 9, 2018 |  BioCentury  |  Product Development

Past not prologue

Loxo Oncology Inc.’s two-year streak of stunning data at ASCO appears to be the result of good decisions on the back of a healthy dose of luck. But it will be a tall order to...
01:30 , Jun 2, 2018 |  BioCentury  |  Product Development

ASCO: Pushing precision’s evolution

As the list of targeted therapies gaining approval grows, encompassing an increasingly broad spectrum of cancers, this year’s ASCO meeting aims to educate clinicians about how to determine which drugs are best in class for...
19:16 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Priority review for Loxo's larotrectinib in tissue-agnostic indication

FDA accepted and granted Priority Review to an NDA for larotrectinib (LOXO-101) from Loxo Oncology Inc. (NASDAQ:LOXO) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion proteins, regardless of...
14:43 , May 29, 2018 |  BC Extra  |  Company News

Priority Review for Loxo's larotrectinib in tissue-agnostic indication

FDA accepted and granted Priority Review to an NDA for larotrectinib (LOXO-101) from Loxo Oncology Inc. (NASDAQ:LOXO) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion proteins, regardless of...
22:56 , May 22, 2018 |  BC Extra  |  Tools & Techniques

Trinity identifies hurdles for tissue-agnostic therapies

While the use of basket trials to test therapies in tissue agnostic, biomarker-based cancer indications is increasing, the long-term implications rely on a handful of factors, many of which may affect postmarket uptake of agents...
16:52 , Apr 13, 2018 |  BC Week In Review  |  Company News

Veracyte, Loxo team up for TRK, RET targeted therapies

Molecular diagnostics company Veracyte Inc. (NASDAQ:VCYT) said Loxo Oncology Inc. (NASDAQ:LOXO) will use Veracyte's Afirma Xpression Atlas platform to develop targeted therapies for thyroid cancers with tropomyosin receptor kinase (TRK) fusions and Ret proto-oncogene (RET)...
15:38 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Loxo completes larotrectinib NDA

Loxo Oncology Inc. (NASDAQ:LOXO) completed submission of a rolling NDA to FDA for larotrectinib (LOXO-101) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion-proteins, regardless of tissue of origin. Larotrectinib...
20:38 , Mar 26, 2018 |  BC Extra  |  Company News

Loxo completes larotrectinib NDA

Loxo Oncology Inc. (NASDAQ:LOXO) completed submission of a rolling NDA to FDA for larotrectinib (LOXO-101) to treat locally advanced or metastatic solid tumors with neurotrophic tyrosine kinase receptor (Trk) fusion-proteins, regardless of tissue of origin. Larotrectinib...
22:25 , Feb 26, 2018 |  BC Extra  |  Politics & Policy

FDA to meet on Orphan tissue-agnostic therapies

FDA said it will hold a public workshop on May 9 to discuss utilizing Orphan Drug designation for tissue-agnostic therapies: drugs and biologics that target a tumor’s specific genetic features rather than its tissue of...
22:52 , Jan 5, 2018 |  BC Week In Review  |  Company News

China investment company SARI acquiring majority stake in Nerviano

China investment company SARI will acquire a 90% stake in cancer company Nerviano Medical Sciences s.r.l. (Nerviano, Italy) for about €300 million ($360 million), which includes an equity investment and a debt restructuring. The deal...