With the approval of Gilead Sciences, Inc.’s (GILD - Free Report) Yescarta, this week saw the approval of the second CAR-T therapy for treating cancer. It is regarded as one of the most advanced immune-oncology treatment options.
Moreover, the FDA has granted priority review to label expansion applications for four major cancer drugs. These include AstraZeneca, plc’s (AZN - Free Report) Lynparza for advanced breast cancer and Imfinzi for an earlier stage of lung cancer, Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo for melanoma patients with high risk of recurrence and Exelixis, Inc.’s (EXEL - Free Report) Cabometyx for advanced renal cell carcinoma (“RCC”).
Meanwhile, Ipsen along with its partner, Exelixis, announced positive results from a phase III study on its hepatocellular carcinoma candidate. Moreover, AbbVie (ABBV - Free Report) entered into an immuno-oncology research collaboration with Harpoon Therapeutics, focused on novel T-cell recruiting biologic therapies. AbbVie will use Harpoon's tri-specific T-cell activating construct platform for developing its immuno-oncology pipeline.
Let’s see the news in details.
Gilead’s acquisition of Kite Pharma for nearly $12 billion has finally paid off with the approval of Yescarta (axicabtagene ciloleucel), the latter’s chimeric antigen receptor T-cell (CAR T) therapy candidate. The FDA approved the therapy for treating relapsed or refractory large B-cell lymphoma (r/rLBCL) in adults who have received two or more lines of systemic therapy.
The various forms of r/rLBCL for which Yescarta is approved include diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and high-grade B-cell lymphoma. This is the second gene therapy to be approved in the United States after Novartis AG’s (NVS - Free Report) Kymriah, which received approval in August for acute lymphoblastic leukemia.
CAR-T therapy is the most advanced form of treating cancer. This is done by modifying the patient’s T-cell, part of the body’s immune system, to fight cancerous cells. The therapy is manufactured specifically for each single patient.
AstraZeneca and partner Merck’s (MRK - Free Report) marketed advanced ovarian cancer drug, Lynparza, received priority review for its supplemental New Drug Application (sNDA) seeking approval in previously treated (chemotherapy) patients with HER2-negative metastatic breast cancer. The FDA is expected to give its decision in the first quarter of 2018. Lynparza is in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.
Meanwhile, the FDA has also granted priority review to AstraZeneca’s sNDA for key cancer drug, Imfinzi for unresectable non-small cell lung cancer. (Read more: AstraZeneca's sNDA for Two Cancer Drugs Gets Priority Review)
Bristol-Myers announced that the FDA has granted priority review to the supplemental Biologics License Application (sBLA) for the label expansion of Opdivo. The company is looking to get the drug approved for treating patients with melanoma, who are at high risk of disease recurrence following complete surgical resection.
The drug is already approved for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Moreover, the company announced that Opdivo, alone or in combination with Yervoy, achieved encouraging results in previously treated small cell lung cancer patients in phase I/II CheckMate -032 study. The Opdivo monotherapy and combo-therapy achieved an objective response rate of 11% and 22%, respectively. (Read more: Bristol-Myers Gets Priority Review for Opdivo Label Expansion)
Exelixis’ renal carcinoma drug, Cabometyx, was also granted priority review by the FDA for its sNDA. The sNDA sought approval of Cabometyx for patients with treatment-naive advanced RCC. The FDA deemed the sNDA to be sufficiently complete with a decision expected on Feb 15, 2018. Moreover, the company’s advanced hepatocellular carcinoma candidate, cabozantinib, achieved statistically significant and clinically meaningful improvement in median overall survival rate over placebo in phase III CELESTIAL study. Exelixis is developing this candidate in partnership with Ipsen.
Meanwhile, Inovio Pharmaceuticals, Inc. (INO - Free Report) initiated a phase Ib/II study, which will evaluate a combination of INO-5401, a T-cell activating immunotherapy and INO-9012, an immune activator with Roche’s anti-PDL1 inhibitor, Tecentriq, in advanced bladder cancer. Immune Design also initiated a pivotal phase III study to support a regulatory application for CMB305for treating patients with synovial sarcoma.
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