Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
Mount Sinai researchers have discovered that normal immune cells called macrophages, which reside in healthy breast tissue surrounding milk ducts, play a major role in helping early breast cancer cells leave the breast for other parts of the body, potentially creating metastasis before a tumor has even developed, according to a study published in Nature Communications.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of Teva’s global safety database for arsenic trioxide
After expanding its partnership with Syndax $SNDX earlier this week on their lead drug, Genentech has beefed up their pipeline of PD-L1 combos with a fresh pact with Stanford spinout Forty Seven.
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.
Celgene Corporation (CELG) and Impact Biomedicines today announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.
GE Healthcare and Roche have launched a partnership to assist clinicians in making better choices and help patients get individualized care.
Eisai Co., Ltd. and Merck (MRK), known as MSD outside the United States and Canada, announced that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).
Gene therapies are an undeniably exciting new frontier for medicine. From Kymriah's genetically modified, cancer-hunting immune cells, to Luxturna's vision-restoring healthy gene replacement, these therapies are fundamentally unlike 20th-century medicines which generally require ongoing drug treatment. Gene therapies can be one-off doses that in effect, cure a specific disease.
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