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Last update 10:26:33 AM EST

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Pfizer Announces Positive Results for its Experimental Breast Cancer Treatment

Pfizer

Pfizer Inc. recently announced promising results from its mid-stage study, evaluating its experimental breast cancer treatment.

The company announced detailed results from the Phase II study, known as PALOMA-1, evaluating palbociclib in combination with letrozole versus letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.

According to Pfizer, patients receiving the combination of palbociclib plus letrozole had a median progression-free survival (PFS) of 20.2 months compared to a median PFS of 10.2 months for patients receiving letrozole only. The improvement in PFS, which was the study’s primary endpoint, was considered statistically significant. Results of the 165-patient study were presented by Dr. Richard S. Finn, associate professor of medicine at University of California, Los Angeles (UCLA) at the American Association of Cancer Research (AACR) Annual Meeting 2014 in San Diego.

“These data demonstrate the potential of palbociclib to be a major advance in the treatment of women with this type of advanced breast cancer,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “We are proud to be at the forefront of research and development with respect to this promising new class of investigational anticancer agents and have initiated a broad clinical development program for palbociclib that includes breast and non-breast cancers.”

Additionally, the initial data showed that patients receiving palbociclib in combination with letrozole had an overall survival (OS) of 37.5 months compared to an OS of 33.3 months for patients receiving letrozole alone. Researchers noted that it is still too early to define the drug’s impact on survival, but the initial improvement in OS, a secondary endpoint, is not considered statistically significant. According to Pfizer, a follow-up on OS analysis will be conducted following the accrual of additional events. The drug was generally well-tolerated.

Palbociclib is among a new class of cancer drugs that target specific proteins to block tumors. It is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation. In April 2013, the US Food and Drug Administration (FDA) granted palbociclib Breakthrough Therapy designation for the initial treatment of women with advanced or metastatic ER+, HER2- breast cancer. The designation was based on interim data from the PALOMA-1 trial.

Pfizer has initiated two late-stage studies evaluating the drug in advanced/metastatic breast cancer. The Phase III study, known as PALOMA-2 or Study 1008, is evaluating palbociclib in combination with letrozole versus letrozole plus placebo as a first-line treatment for post-menopausal patients with ER+, HER2- advanced breast cancer. PALOMA-3, also known as Study 1023, is evaluating palbociclib in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor positive (HR+), HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy.

Source: Pfizer Inc.

Last updated: 4/7/14; 3:05pm EST

FDA Panel Recommends Exact Sciences' Colorectal Cancer Screening Test

Exact Sciences

A panel of the US Food and Drug Administration (FDA) advisors has unanimously endorsed Exact Sciences Corp’s colorectal cancer screening test for FDA approval.

The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted ten to zero that the benefits of Exact Sciences’ Cologuard test outweigh the risks. Exact Sciences said that the panel determined that Cologuard is safe, effective and has a favorably risk benefit profile.

Cologuard is a stool-based DNA (sDNA), non-invasive colorectal cancer screening test. Cologuard requires patients to collect a stool sample at home and send it to a lab where the sample will be processed through a series of sophisticated laboratory procedures to isolate specific DNA targets. The targeted DNA is then amplified and analyzed for molecular alterations associated with cancerous and pre-cancerous conditions of the colon and rectum. Physicians will discuss results with their patients, referring patients for a diagnostic colonoscopy if results are positive.

“We are pleased the Committee strongly supported Cologuard’s approval,” Kevin T. Conroy, chairman and chief executive of Exact Sciences. “We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program.”

In a study published last week in the New England Journal of Medicine, Cologuard detected 92 percent of cancers and 42 percent of advanced precancerous lesions.

An alternative investigational DNA-based test for detecting colon cancer was also recommended by the FDA panel this week. Epigemonics’ Epi proColon was recommended for approval in a 5-4 vote, with one abstention. Epi proColon is designed to use a blood sample, rather than a stool sample.

Source: Exact Sciences Corp

Last updated: 3/28/14; 3:10pm EST

FDA Panel Narrowly Recommends Epigenomics' DNA Colon Cancer Test

epi pro colon

Epigenomics’ experimental blood-based colorectal cancer screening test was recommended by a panel of advisers.

Although the vote was in favor of approval, the numbers were close. The Molecular and Clinical Genetics Panel of the US Food and Drug Administration’s (FDA) Medical Devices Advisory Committee voted 5-4, with one abstention, that the benefits outweighed the risks for use of Epigenomics’ Epi proColon in patients who meet the criteria. The FDA is not required to follow the panel’s recommendation, but often time does.

In addition to the clinical data, the committee also discussed risk mitigation strategies that should be considered in addition to the current proposed labeling.

The panel voted 9-0, with one abstention, in favor of adequate evidence of safety, and 5-6 against adequate evidence of effectiveness, with panel chair Ronald Pryzgodzki, MD, acting director of biomedical laboratory R&D within the Department of Veterans Affairs, voting against adequate evidence of effectiveness to break the tie.

“We thank the Committee members for their thorough considerations and the insightful discussion,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We are pleased with the outcome of today’s meeting and appreciate the support expressed by the CRC community. We look forward to working with FDA and the community to continue the fight against CRC. As the only blood-based test for the early detection of CRC, the potential launch of Epi proColon will help to significantly increase the number of people being tested early for CRC and help met the objective of 80% screening compliance of the US population, as pursued by US guideline bodies.”

Source: Epigenomics

Last updated: 3/27/14; 1:45pm EST

Novartis' Investigational Compound Shows Promise in Patients with a Rare Form of Lung Cancer

Novartis

Novartis recently announced that its investigational breakthrough therapy shrank tumors in more than half of patients with a rare form of lung cancer.

According to results published in the New England Journal of Medicine (NEJM), Novartis’ investigational compound LDK378 (ceritinib) achieved an overall response rate (ORR), including complete response and partial response, of 58 percent and a median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.

Novartis’ ceritinib has been declared a breakthrough therapy by the US Food and Drug Administration (FDA), intended to expedite review of the drug. The drug targets an anomaly in the ALK gene, which plays a crucial role in about five percent of NSCLC cases, or about 10,000 patients annually in the US. The first ALK-inhibitor approved by the FDA is Pfizer’s Xalkori (crizotinib), a drug that is very effective in causing rapid regression of lung cancer, but one that patients’ tumors inevitably become resistant to.

Novartis’ study evaluated 114 ALK+ NSCLC patients treated with its LDK378 compound, including patients who had progressed during or following treatment with crizotinib and those who had not received prior treatment with an ALK inhibitor.

“The majority of patients in the study experienced a clinical response to LDK378. In addition, responses were seen in untreated lesions in the central nervous system in patients who previously received crizotinib,” said lead investigator Alice T. Shaw, MD, PhD, Massachusetts General Hospital Cancer Center, Boston. “These results are important because most patients experience a disease relapse less than a year after starting crizotinib and have limited treatment options.”

The most frequent adverse events were nausea, diarrhea, vomiting, fatigue, and increased alanine aminotransferase levels. Preliminary data were first presented at the 2013 American Society of Clinical Oncology Annual meeting. The study is ongoing with more data to become available. In January, Novartis announced that it had filed for regulatory approval of crizotinib based on data from the study.

“These pivotal data published in NEJM served as the basis for our first regulatory filing for LDK378,” said Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. “We are pleased that the FDA has accepted our application, and we look forward to working with the FDA and health authorities worldwide to bring this important treatment option to patients in need as swiftly as possible.”

Source: Novartis

Last updated: 3/27/14; 10:30am EST

Xtandi Receives Approval for Treatment of Prostate Cancer in Japan

astellas medivation

Astellas Pharma Inc. recently announced that Astellas has obtained the marketing approval of Xtandi for the treatment of prostate cancer.

According to the company, oral androgen receptor signaling inhibitor Xtandi (enzalutamide) capsules 40 mg is now approved for the treatment of patients with castration-resistant prostate cancer in Japan. The application was filed for approval in Japan in May 2013.

Xtandi is already approved in more than 35 countries for the treatment of prostate cancer. The US Food and Drug Administration (FDA) approved the drug in August 2012 and health regulatory agents in the European Union approved the drug in June 2013 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received chemotherapy docetaxel.

Xtandi is a once-daily, oral androgen receptor signaling inhibitor. It inhibits multiple steps in the androgen receptor pathway, which has shown to decrease cancer cell growth and can induce cancer cell death, known as apoptosis. Astellas and Medivation, Inc. partnered for Xtandi. With Xtandi’s approval in Japan, Medivation stands to receive a $15 million milestone payment.

According to Astellas, net sales of Xtandi in the US in 2013 were $392.4 million. Astellas and Medivation are now looking to expand Xtandi’s label for patients who have not received treatment with chemotherapy. The companies recently filed a supplemental New Drug Application (sNDA) seeking approval of Xtandi for the treatment of men with metastatic-castration resistance prostate cancer who have not received chemotherapy.  The companies also intend to apply for EU approval of this indication later this year.

Source: Astellas

Last updated: 3/26/14; 12:25pm EST