In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in the first-line endometrial cancer regardless of biomarker status.
Tag Archive for: drug labeling
Takeda secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
The agency stated that companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
These factors, along with bluebird bio’s failure to receive a priority review voucher, all hurt the company’s stock price following Lyfgenia’s approval.
The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
When given concurrently with chemoradiotherapy, AstraZeneca’s Imfinzi in a late-stage lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.