Emphasizing April’s vote of concern about the safety of PI3K inhibitors, the U.S. FDA’s Oncologic Drugs Advisory Committee said privately held Secura Bio Inc.’s Copiktra (duvelisib) is more of a hindrance than a help. The adcom voted 8-4 on Sept. 23 that it sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura argued that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression-free survival.

Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21. The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong.

Although it wasn’t a shutout, Spectrum Pharmaceuticals Inc. didn’t get the support it needed from a U.S. FDA advisory committee Sept. 22 for its non-small-cell lung cancer candidate, poziotinib, which it has proposed marketing as Pozenveo.

Researchers have designed a 3D model of lung cancer that is composed of bronchial epithelial, fibroblasts, epithelial, lung adenocarcinoma and immune cells grown in different layers in a matrigel.