Shots:
The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor
Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor
Trial showed meaningful & durable…
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GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer
As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…
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Guardant Health has entered into a multi-year strategic collaboration with Nuvalent to support the development & potential commercialization of Nuvalent’s oncology pipeline using the Guardant Infinity platform
The partnership will use Guardant’s tissue & liquid biopsy tests to support Nuvalent’s global clinical studies & evaluate companion diagnostic development for Nuvalent’s investigational cancer therapies
The…
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The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC
NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

