publication date: Mar. 20, 2020

Drugs & Targets

China accepts sNDA for Zejula in ovarian cancer indication

The China National Medical Products Administration accepted a supplemental New Drug Application for Zejula (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Zai Lab Ltd. sponsors Zejula.

“We believe Zejula is a potential best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier,” Samantha Du, founder and chief executive officer of Zai Lab, said in a statement.

The PRIMA study conducted by GlaxoSmithKline demonstrated that Zejula treatment resulted in a 38% reduction in the risk of disease progression or death in the overall study population when compared to placebo. Zejula also demonstrated benefits in all patient subgroups. For patients whose cancer is associated with homologous recombination deficiency positive status, Zejula treatment resulted in a 57% reduction in the risk of disease progression or death.

FDA previously accepted GSK’s sDNA application for Zejula as first-line maintenance treatment for ovarian cancer based on the PRIMA study.


The U.K. removes Keytruda from Cancer Drug Fund in bladder cancer indication

England’s National Institute for Health and Care Excellence has rejected Keytruda (pembrolizumab) in patients who receive locally advanced or metastatic urothelial carcinoma who have had platinum-containing chemotherapy.

Merck sponsors Keytruda.

The drug has since been removed from the Cancer Drug Fund, where it was available previously.

The National Institute for Health and Care Excellence said it couldn’t recommend the drug because of cost-effectiveness.


FDA approves Herzuma, equivalent of Herceptin, in indications

FDA has approved Herzuma (trastuzumab-pkrb) for injection in the same indications as the biosimilar Herceptin.

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, sponsor Herzuma.

Indications include adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. In these indications, patients should be selected for therapy based on FDA-approved companion diagnostic for a trastuzumab product.


Deaya, Pfizer collaborate on clinical trials

Ideaya Biosciences Inc. and Pfizer Inc. have formed a clinical trial collaboration and supply agreement.

The collaboration includes an Ideaya-sponsored clinical combination study of IDE196, a protein kinase C inhibitor—and binimetinib, a MEK inhibitor that Pfizer has exclusive rights to in the U.S. and Canada, in GNAQ or GNA11 hotspot mutated solid tumors, including metastatic uveal melanoma, cutaneous melanoma, and colorectal cancer.

Ideaya and Pfizer will form a joint development committee, and there will be joint decision making and data sharing of the clinical trial results between the parties. Ideaya will sponsor the study, and Pfizer will supply binimetinib for the study. The clinical combination trial is targeted to initiate in mid-2020.

The clinical combination study will evaluate whether inhibition of the MAP-kinase pathway at two nodes, through upstream PKC and downstream MEK, will enhance the response rate and depth and durability of clinical benefit in patients whose solid tumors harbor GNAQ or GNA11 hotspot mutations. The clinical trial will also study pharmacokinetics of each agent and tolerability of the combination.

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