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Cancer Space Update: New Regulatory Status for 3 Major Drugs

Zacks

There have been hardly any notable developments in the first week as the market continues to be in the holiday mood. In fact, Trump’s $1.5 trillion gift before the New Year in the form of the tax reform is still keeping the markets buoyant. Coming to the developments in the cancer space, Merck & Co., Inc.’s MRK Keytruda received approval in Japan for urothelial carcinoma. Seattle Genetics, Inc. SGEN announced FDA’s acceptance of a regulatory filing seeking label expansion of Adcetris as frontline treatment of advanced classical Hodgkin lymphoma. The FDA granted Breakthrough Therapy designation (“BTD”) to Novartis’ NVS breast cancer drug, Kisqali during the week.

Merck and Seattle Genetics carry a Zacks Rank #3 (Hold) while Novartis holds a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Let’s discuss the news in details.


Merck Announces Keytruda’s Approval in Japan: Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) has received approval in Japan as treatment for previously-treated patients with urothelial carcinoma (“UC”), a type of bladder cancer. With this approval, Keytruda is now approved for four indications in Japan.

We remind investors that Keytruda is approved for treating UC in the United States and Europe in first- and second-line settings. The drug is approved for several cancer indications including non-small cell lung cancer in combination with Eli Lilly's (LLY) Alimta and carboplatin. (Read more: Merck's Keytruda Gets Approved for Bladder Cancer in Japan)

Seattle Genetics' sBLA for Adcetris Granted Priority Review: Seattle Genetics announced that the FDA has accepted the sBLA seeking label expansion of lymphoma drug, Adcetris and also granted priority review. The sBLA seeks approval of Adcetris in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA has also set an action date of May 1, 2018. (Read more: Seattle Genetics' Adcetris sBLA Gets FDA Priority Review)

Novartis’ Kisqali Gets Second Breakthrough Designation: Novartis announced that the FDAgranted BTD to Kisqali for initial endocrine-based treatment of HR+/HER2 advanced or metastatic breast cancer in pre- or peri-menopausal women. The company is developing the drug in combination with tamoxifen or an aromatase inhibitor for this indication. The drug was granted BTD in 2016 for the same cancer indication in postmenopausal women. (Read more: Novartis Gets Second Breakthrough Designation for Kisqali)

Apart from these developments, Inovio Pharmaceuticals, Inc. INO announced the amendment of its agreement with its Chinese partner, ApolloBio Corporation, related to development of its DNA immunotherapy product, VGX-3100, in Greater China. Per the amended agreement ApolloBio will make an upfront payment of $23 million, higher than the previously agreed $15 million and also excluded ApolloBio’s right to purchase Inovio stock. The candidate is currently being evaluated in a phase III study for the treatment of human papillomavirus (HPV)-related cervical pre-cancer.

Meanwhile, Exelixis, Inc. EXEL amended the protocol for its phase Ib study of cabozantinib in combination with Roche Holdings’ RHHBY Tecentriq in patients with locally advanced or metastatic solid tumors. The study will addfour new expansion cohorts to include patients with NSCLC, CRPC, RCC and UC. Celsion Corporation CLSN announced that the FDA has accepted the design of its phase I/II study – Ovation II – in ovarian cancer and cleared it for initiation. The study will evaluate its DNA-based immunotherapy, GEN-1, as localized treatment for stage III/IV ovarian cancer in newly diagnosed patients.

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