Celgene plans to submit sNDA by end of 2019
Celgene plans additional studies with the AIDS Malignancy Consortium in U.S. and sub-Saharan Africa
Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma.
Kaposi sarcoma is a multicentric tumor caused by Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8. Patients suffer multiple lesions on the skin and oral mucosa, and at times other organs such as the lungs or gastrointestinal mucosa. Kaposi sarcoma most commonly arises in persons infected with HIV. There is a substantial need for new treatments because there are no approved therapies for HIV-positive patients who are refractory to or intolerant of systemic chemotherapy. Although the use of combination anti-retroviral treatments (cART or HAART) has reduced the incidence of advanced Kaposi sarcoma in the United States, there are still nearly 2000 new cases each year. The disease is more highly prevalent in areas of the world where HIV treatments are less available, such as sub-Saharan Africa, and in some countries is the most common tumor in men overall.
“The encouraging news of the FDA Breakthrough Therapy designation for POMALYST in Kaposi sarcoma reflects the urgency in accelerating the development of therapies to address diseases of this type,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We will continue to work closely with the agency to move this program forward for patients with this rare and serious cancer.”
The Breakthrough Therapy designation was granted by the FDA on the basis of the results of a clinical study performed under a Cooperative Research and Development Agreement (CRADA) by a team led by Dr. Robert Yarchoan, of the HIV and AIDS Malignancy Branch within the Center for Cancer Research of the National Cancer Institutes (NCI). The results of that study, published in the Journal of Clinical Oncology (MN Polizzotto et al, JCO, 2016, 34, 4125-31), evaluated POMALYST in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy.
According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases.
Celgene plans to submit a supplemental New Drug Application for POMALYST in this disease area by the end of 2019.
Celgene also has two additional studies planned in this disease. In partnership with the AIDS Malignancy Consortium (AMC), a U.S. multicenter study will be performed to confirm and extend the results of the NCI study. The AMC is also sponsoring a second study in sub-Saharan Africa, where Kaposi sarcoma continues to be a serious problem. This program is a part of the Celgene Global Health effort to discover and develop new drugs for diseases that affect patients in the lower- and middle-income countries where health systems and medical resources are less advanced.
POMALYST is not approved for Kaposi sarcoma in any country.
About POMALYST
POMALYST is one of Celgene’s IMiD® agents - proprietary small molecule, orally-available compounds for the treatment of some blood cancers. IMiD agents are hypothesized to have multiple mechanisms of action and have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds in different settings and diseases.
U.S. Safety Information
Indication
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
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Important Safety Information |
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WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity
POMALYST is only available through a restricted distribution program called POMALYST REMS®. Venous and Arterial Thromboembolism
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.
In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).
DRUG INTERACTIONS
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%.
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information, including Boxed WARNINGS.
About Celgene Global Health
Celgene Global Health (CGH) is a dedicated R&D unit of Celgene committed to discovering, developing and delivering novel drugs for Diseases of the Developing World (DDWs). Collaborating with non-profit and academic institutions around the globe, CGH has utilized the company’s library of more than 400,000 compounds to evaluate candidates for drug development for DDWs. More than ten discovery and development programs are ongoing in several disease areas such as malaria and tuberculosis. For more information, visit https://www.celgene.com/responsibility/global-health/
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel
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