The FDA cleared Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small-cell lung cancer, also granting accelerated approval to the tyrosine kinase inhibitor for adult and pediatric patients (12 and older) with solid tumors that have a NTRK gene fusion.

During its recent conference call on earnings, Fate Therapeutics Inc. gave out what one analyst called "a wake-up call for the entire industry" with regard to cost of goods, just as more are starting to awaken regarding the company's potential therapeutically.

The FDA cleared oral pretomanid, developed by the non-profit TB Alliance, under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) as part of a three-drug, six-month, all-oral regimen for the treatment of tuberculosis (TB) in people with extensively drug-resistant disease (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

Dublin-based Jazz Pharmaceuticals plc's buyout of Cavion Inc. via merger with a subsidiary had some on Wall Street scratching their chins, as the takeover undoubtedly adds to the central nervous system (CNS) pipeline but with lingering development risks.

Analysts had questions aplenty for Nektar Therapeutics Inc. about cancer drug candidate bempegaldesleukin ("bempeg," NKTR-214) after the firm made known some apparent manufacturing problems with the compound, a CD122-preferential interleukin-2 pathway agonist designed to stimulate the patient's own immune system and fight various cancer types.

As expected, Rhythm Pharmaceuticals Inc. rolled out positive top-line results from two pivotal, phase III trials evaluating setmelanotide, the company's melanocortin-4 receptor (MCR4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities. 

Leap Therapeutics Inc. said its anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.), turned up higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer (GEJ/GC) whose tumors expressed high levels of DKK1 (DKK1-high).

Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements." 

Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%.