Gina Columbus

Articles by Gina Columbus

The Food and Drug Administration (FDA) has granted an approval to Trazimera (PF-05280014; trastuzumab-qyyp), a Herceptin (trastuzumab) biosimilar, to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

In topline findings from the phase 3 TITAN trial (NCT02489318) announced today by Janssen, Erleada (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) versus placebo in patients with metastatic castration-sensitive prostate cancer.

The FDA has granted an approval to Ontruzant (SB3; trastuzumab -dttb), a Herceptin (trastuzumab) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

The Food and Drug Administration (FDA) has granted the investigational BTK inhibitor zanubrutinib (BGB-3111) a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received at least one prior therapy, according to BeiGene, the company manufacturing the agent.

The Food and Drug Administration has approved Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, paclitaxel, the treatment combination known as ABCP, for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).

The Food and Drug Administration has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with advanced RET fusion–positive thyroid cancer who require systemic therapy, have progressed on prior treatment, and have no other acceptable alternative treatment options, according to a statement from Loxo Oncology, the developer of the selective RET inhibitor.

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