QIAGEN announced the Japanese Pharmaceuticals and Medical Device Agency has approved the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer. The therascreen EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
