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PFIZER RECEIVES FDA APPROVAL FOR MYLOTARG.

The U.S. Food and Drug Administration has approved MYLOTARG (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG is the first therapy with an indication that includes pediatric AML. It is also the only AML therapy that targets CD33, an antigen expressed on AML cells in up to 90% of patients.

MYLOTARG was originally approved in 2000 at a higher dose under the FDA's accelerated approval program for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were 60 years or older and who were not considered candidates for other cytotoxic chemotherapy. In 2010, Pfizer voluntarily withdrew MYLOTARG in the U.S. after a confirmatory trial failed to show clinical benefit and there was a higher rate of fatal toxicity compared to chemotherapy. MYLOTARG has remained on the market in Japan and has been available to individual patients through Pfizer's compassionate use programs. Due to the critical unmet need for patients with AML, there remained great interest among AML clinicians to evaluate MYLOTARG using different doses and different schedules. These independent investigators, with Pfizer's support, conducted clinical trials that yielded more information on the efficacy and safety of MYLOTARG.

The approval of MYLOTARG is based on several investigator- led clinical trials, including ALFA-0701, AML-19 and MyloFrance-1.

The ALFA-0701 trial was a Phase 3, multicenter, randomized, open-label study of 271 patients with newly-diagnosed de novo AML, using a new, lower fractionated dose of MYLOTARG. Patients received MYLOTARG 3 mg/m2 on days 1, 4 and 7 in combination with conventional chemotherapy or chemotherapy alone. The primary endpoint was event-free survival (EFS). Administering MYLOTARG (n=135) in addition to standard induction chemotherapy resulted in a significant improvement in EFS compared with chemotherapy alone (n=136) in patients with newly diagnosed AML. Event-free survival was 17.3 months for patients receiving MYLOTARG compared with 9.5 months for those receiving chemotherapy alone (HR = 0.56 [95% CI: (0.42, 0.76)]).1

Study AML-19 was a multicenter, randomized, open-label Phase 3 study comparing single agent MYLOTARG (n=118) to best supportive care (n=119) for elderly patients who could not tolerate other AML therapies. As initial treatment, patients received MYLOTARG 6 mg/m2 on day 1 and MYLOTARG 3 mg/m on day 8. As continued treatment, patients without evidence of disease progression received MYLOTARG 2 mg/m2 on day 1 every 4 weeks. The efficacy of MYLOTARG was established on the basis of a significant improvement in overall survival (OS). Median OS was 4.9 months for patients receiving MYLOTARG compared with 3.6 months for patients receiving best supportive care (HR=0.69 [95% CI: 0.53-0.90] [2-sided p=0.005]).1

MyloFrance-1 was a Phase 2, single-arm, open-label study of 57 adult patients in first relapse. Patients received single agent MYLOTARG 3mg/m2 on days 1, 4 and 7. The efficacy of MYLOTARG was established on the basis of complete remission (CR) rate and duration of remission. In the trial, 15 (26%; 95% CI: 16%-40%) patients achieved a complete remission (CR) and median relapse-free survival (RFS) was 11.6 months.1

Pfizer helps patients gain access to Pfizer medicines, including MYLOTARG, and related educational tools, resources and services, regardless of their financial or health insurance status through the company's patient assistance programs. Patients can visit www.MYLOTARG.com or call 1-877-744-5675 to learn more.

About AML

Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults and accounts for approximately 80% of all cases of acute leukemia.2 About 21,380 people are expected to be diagnosed with AML in the United States in 2017. The majority of AML cases occur in adults, but about 500 children are diagnosed with AML each year. Acute myeloid leukemia is the second most common leukemia in children. The majority of children (85%) will achieve a response after initial treatment, with approximately 5% being refractory to treatment. Additionally, approximately 30% of children will have their disease return. Only one in four patients with AML survive longer than five years.4

About MYLOTARG (gemtuzumab ozogamicin)

MYLOTARG is an antibody-drug conjugate (ADC) composed of the cytotoxic agent calicheamicin, attached to a monoclonal antibody (mAB) targeting CD33, an antigen expressed on the surface of myeloblasts in up to 90 percent of AML patients. When MYLOTARG binds to the CD33 antigen on the cell surface it is absorbed into the cell and calicheamicin is released causing cell death.

MYLOTARG is commercially available in Japan where it is approved for the treatment of patients with relapsed or refractory CD33-positive AML who are not considered candidates for other cytotoxic chemotherapy.

MYLOTARG originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing, clinical development and commercialization activities for this molecule.

About Pfizer Oncology

Pfizer Oncology pursues treatments that have a meaningful impact on those living with cancer. Pfizer Oncology is helping to redefine life with cancer. Their strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines.

Pfizer Inc.

Pfizer's global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. They collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

For more information, visit www.pfizer.com or call 212/733-8160.
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Publication:Biotech Business
Date:Jun 1, 2017
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