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Cancer Space Update: Label Expansion for Three Major Drugs

With a busy earnings season almost coming to an end after an impressive run, we are again focused on latest cancer updates happening every week. The week gone by saw three cancer drugs receiving FDA approval for new indications – Roche Holding AG’s RHHBY Gazyva, Pfizer Inc.’s PFE Sutent and AstraZeneca PLC’s AZN Faslodex. However, an interesting product in development is a cancer vaccine that Moderna Therapeutics and Merck MRK are working on. Merck has provided a fund of $200 million to develop the vaccine in combination with its anti-PD-1 therapy, Keytruda, in return for a right to half of the potential sales. The vaccine will be personalized and Moderna has just developed one for its first enrolled patient. Top-line data is expected in September 2019. AVEO Pharmaceuticals, Inc.’s AVEO also announced the launch of its first drug, Fotivda, which was approved in Europe for treating kidney cancer in August 2017.

Recap of the Week’s Most Important Stories

AstraZeneca's Faslodex Approved for Combination Use: The FDA approved a new indication for breast cancer drug, Faslodex, on Nov 15. The label of Faslodex will now be expanded to include combination use with Eli Lilly’s (LLY) new CDK4/6 inhibitor Verzenio to treat women with HR+, HER2- advanced or metastatic breast cancer whose disease has progressed after endocrine therapy. (Read more: AstraZeneca's Faslodex Gets FDA Nod for Use With Verzenio)

Astrazeneca PLC Price and Consensus


Astrazeneca PLC Price and Consensus | Astrazeneca PLC Quote

Pfizer’s Sutent Approved as Adjuvant Treatment for Kidney Cancer: The FDA approved label expansion of cancer drug Sutent (sunitinib malate). With the latest FDA approval, Sutent’s label has been expanded to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma ("RCC"). This approval marks the first and only adjuvant treatment for recurrent RCC. Sutent is presently marketed for the first-line treatment of advanced RCC and has been the standard-of-care for this indication since its approval a decade ago.

An application for use in the same patient population is also under review in the EU.

Pfizer, Inc. Price and Consensus


Pfizer, Inc. Price and Consensus | Pfizer, Inc. Quote

Roche’s Gazyva Approved in First-line Setting for Blood Cancer: Roche obtained FDA approval for Gazyva in combination with chemotherapy for previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The patients who respond to the combination therapy will continue to be treated with Gazyva alone. The approval was based on superior progression-free survival achieved by the drug compared to Rituxan in phase III GALLIUM study.

The drug is already approved for use in combination with chlorambucil to treat chronic lymphocytic leukemia ("CLL") in adults who have not had previous CLL treatment.

Roche Holding AG Price and Consensus


Roche Holding AG Price and Consensus | Roche Holding AG Quote

AVEO Adds First Drug to its Commercial Portfolio: AVEO and its partner EUSA Pharma announced the launch of its kidney cancer drug, Fotivda in the European Union. The company expects to initiate selling in Europe starting with Germany. The drug received approval in August as first-line treatment of advanced RCC in adult patients. The drug is also approved in patients who are not treated with VEGFR and mTOR pathway inhibitor therapy, following disease progression after a cytokine-based therapy. The approval and launch was a major milestone for AVEO as Fotivda is the first and only marketed drug in the company’s portfolio. While the acceptance of the drug is yet to be seen, it cuts AVEO’s dependence on funds from collaboration to some extent.

AVEO Pharmaceuticals, Inc. Price and Consensus


AVEO Pharmaceuticals, Inc. Price and Consensus | AVEO Pharmaceuticals, Inc. Quote

Apart from these label expansions and drug launches, the buzzword of the immuno-oncology segment, CAR-T therapy, grabbed the headlines. In a major boost to Celgene Corporation CELG and Bluebird Bio, Inc. BLUE, the FDA granted breakthrough therapy designation to their CAR-T therapy candidate, bb2121. The candidate also received access to PRIority Medicines in Europe. bb2121 is being developed for previously treated patients with multiple myeloma. With these regulatory designations, the development is expected to expedite.

Meanwhile, Bayer signed a collaboration agreement with a small U.S. based company, Loxo Oncology, which gives it access to the latter’s pipeline candidate, LOXO-195. With this, Bayer gets an entry into the field of cancer treatment where the drug attacks cancer based on genetics rather than attacking the organ of origin. Moreover, Celsion submitted its phase I/II clinical study protocol to the FDA, which will evaluate its DNA-based immunotherapy, GEN-1, as localized treatment of ovarian cancer.

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