Product

<!DOCTYPE html> <html lang="en"> <head> <title>Product</title> <meta name="description" content="Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous), and PB357 in 2011. In 2022, Puma in-licensed global research and development and commercial rights to alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Puma has been focused on developing the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. Puma believes that neratinib has clinical applications in the treatment of several other cancers as well, including non-small cell lung cancer and other solid tumor types that over-express or have a mutation in HER2. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. Puma commenced commercial sales of the drug in 2017 and it is marketed in the United States as NERLYNX® tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. Commercial sales commenced in the European Union in 2019. Puma has entered into additional exclusive license agreements with various parties to commercialize NERLYNX in regions outside the United States, including the European Union, Canada, Latin America, Greater China, Israel, Southeast Asia, Australia, New Zealand, South Korea, the Middle East, and parts of Africa. Puma plans to continue to pursue the commercialization of NERLYNX outside the United States. Alisertib is an adenosine triphosphate鈥揷ompetitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in Clinical Trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia. Puma initially intends to focus the development of alisertib on the treatment of patients with metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer and small cell lung cancer. Alan H. Auerbach has served as Chairman of the Board, CEO and President of Puma Biotechnology, Inc. since he founded the Company in 2010. Prior to Puma, Mr. Auerbach served as CEO, President and a Member of the Board of Directors of Cougar Biotechnology, Inc., from its inception in 2003 until its acquisition by Johnson & Johnson in July 2009. From July 2009 until January 2010, Mr. Auerbach served as Co-Chairman of the Integration Steering Committee at Cougar (as part of J&J), providing leadership and oversight for the development and global commercialization of Cougar's lead product candidate, abiraterone acetate. Abiraterone (Zytiga) was approved for the treatment of metastatic prostate cancer in the U.S. in April 2011 and in the EU in September 2011. Prior to founding Cougar, from June 1998 to April 2003 Mr. Auerbach was Vice President, Senior Research Analyst at Wells Fargo Securities, where he was responsible for research coverage of small- and mid-cap biotechnology companies, with a focus on oncology. He had primary responsibility for technical, scientific and clinical due diligence, and selected biotechnology companies followed by the company. In 2002, Mr. Auerbach ranked second in the NASDAQ/Starmine survey of analyst performance for stock picking in biotechnology. From August 1997 to May 1998, Mr. Auerbach was Vice President, Research Analyst at the Seidler Companies, Inc., where he was responsible for research coverage of small-cap biotechnology companies. Prior to his work as a securities analyst, Mr. Auerbach worked for Diagnostic Products Corporation, where he designed and implemented Clinical Trials in the field of oncology. Mr. Auerbach received a B.S. in Biomedical Engineering from Boston University and an M.S. in Biomedical Engineering from the University of Southern California. Puma Biotechnology, Inc., founded in 2010, is headquartered in Los Angeles, California. Additional information may be found at https://www.pumabiotechnology.com. NERLYNX® is a registered trademark of Puma Biotechnology, Inc." /> <meta name="keywords" content="Puma Biotechnology, biotechnology, nerlynx, neratinib, neratinib tablets, breast cancer, early stage, metastatic, drug development, pb272, Clinical Trials, oncology, her2+, biopharmaceutical, in-licensing, cancer treatment, oncology, extended adjuvant therapy, non-small cell lung cancer, biliary cancer, ExteNET, SUMMIT, FB-10 , CONTROL, NALA, tyrosine kinase inhibitor, TBCRC-022, HER2-mutated, EGFR, EGFR exon 18, EGFR exon 18-mutant, HER-Seq, alisertib, aurora kinase A, adenosine triphosphate鈥揷ompetitive and reversible inhibitor of aurora kinase A, inhibitor of aurora kinase A, disruption of mitosis, apoptosis of rapidly proliferating tumor cells, apoptosis of tumor cells, breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma, acute myeloid leukemia, metastatic estrogen receptor-positive (ER-positive) HER2-negative breast cancer, triple-negative breast cancer, HER2-negative breast cancer, ER-positive breast cancer" /> <meta name="author" content="Puma Biotechnology, Inc." /> <meta charset="UTF-8" /> <meta name="format-detection" content="telephone=no" /> <link rel="stylesheet" href="../css/style.min.css?_v=20241125172350" /> <link rel="shortcut icon" href="../favicon.ico" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> </head>  <script async src="https://www.googletagmanager.com/gtag/js?id=G-CN3D3P6NW6"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-CN3D3P6NW6'); </script> <script> const PATH = '../img/'; </script> <body> <div class="wrapper"> <header class="header" data-lp> <div class="header__container"> <div class="header__content"> <a href="../index.html" class="header__logo"> <picture> <source srcset="../img/logo.webp" type="image/webp" /> <img src="../img/logo.png" data-no-lazy 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cancer.</p> </div> <div class="hero__bg-image"> <img src="../img/hero/hero_bg.png" data-no-lazy decoding="async" width="1440" height="697" alt="" /> </div> </div> </div> </section>  <section class="page__product-page product-page"> <div class="product-page__container"> <div class="product-page__top-row"> <h3 class="product-page__title title">Our Product</h3> <p class="product-page__descr">The Product Information provided below is intended for residents of the U.S. only.</p> </div> <div class="product-page__body"> <div class="product-page__banner banner-product"> <div class="banner-product__inner"> <div class="banner-product__image"> <img src="../img/product-page/pp-01.png" width="240" height="252" alt="Puma Biotechnology, Inc." /> </div> <div class="banner-product__info"> <div class="banner-product__logo"> <img src="../img/product-page/pp-logo.png" width="234" height="90" alt="Puma Biotechnology, Inc." /> </div> <p class="banner-product__descr">The first and only FDA-approved HER2-directed post-adjuvant treatment for early and metastatic breast cancer.</p> <div class="banner-product__buttons"> <a href="https://nerlynxhcp.com/pdf/full-prescribing-information.pdf" class="banner-product__button banner-product__button--orange button" target="_blank"> <span>full prescribing information</span> <svg width="16" height="16"> <use xlink:href="../img/icons/icons-new.svg#svg-arrow-right-from-bracket-solid"></use> </svg> </a> <a href="https://nerlynx.com/" class="banner-product__button banner-product__button--blue button" target="_blank"> <span >visit nerlynx.com <br /> for more information</span > <svg width="16" height="16"> <use xlink:href="../img/icons/icons-new.svg#svg-arrow-right-from-bracket-solid"></use> </svg> </a> </div> </div> </div> </div> <div class="product-page__descr"> <h3 class="accent-color">What is NERLYNX tablets?</h3> <ul> <li>NERLYNX is a prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.</li> <li>NERLYNX is also used with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer.</li> </ul> <p>It is not known if NERLYNX is safe and effective in children.</p> <h3>IMPORTANT SAFETY INFORMATION</h3> <p class="accent-color">What is the most important information I should know about NERLYNX (ner links)?</p> <h3>NERLYNX may cause serious side effects, including:</h3> <p><b>Diarrhea:</b> Diarrhea is a common side effect of NERLYNX, but it can also be severe. Diarrhea may lead to loss of too much body salts and fluid, which can cause dehydration. Your healthcare provider will prescribe NERLYNX in one of two ways to help manage diarrhea:</p> <h4>Full dose of NERLYNX:</h4> <ul> <li>Your healthcare provider will prescribe the antidiarrheal medicine loperamide for you during your first 2 months (56 days) of treatment with NERLYNX and then as needed. Your healthcare provider will tell you exactly how much and how often to take this medicine.</li> <li>If you are prescribed the full dose of NERLYNX from the start of your treatment, be sure that your healthcare provider also prescribes antidiarrheals with NERLYNX. You should start taking loperamide with your first dose of NERLYNX.</li> <li>After 2 months (56 days) of treatment with NERLYNX, follow your healthcare provider's instructions about taking loperamide as needed to control diarrhea.</li> </ul> <h4>A lower starting dose of NERLYNX:</h4> <ul> <li>Your healthcare provider will start you on a lower dose of NERLYNX for the first 2 weeks of treatment and then increase you to a full dose NERLYNX regimen. Tell your healthcare provider right away if you develop diarrhea; you may be prescribed loperamide as needed.</li> </ul> <h4>To help prevent or reduce diarrhea during treatment with NERLYNX:</h4> <ul> <li>Your healthcare provider may also need to give you additional antidiarrheals, fluids, and electrolytes to manage diarrhea when you start treatment with NERLYNX. Follow your healthcare provider's instructions on how to take antidiarrheal medicines.</li> <li>Always take antidiamrrheals exactly as your healthcare provider tells you.</li> <li>While taking antidiarrheals, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.</li> <li>Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or you have diarrhea that does not go away.</li> <li>Call your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.</li> </ul> <p>Your healthcare provider may change your dose of NERLYNX, temporarily stop, or completely stop NERLYNX if needed to manage your diarrhea.</p> <p> See <a href="#side-effects"><b>"What are the possible side effects of NERLYNX?"</b></a> for more information about side effects. </p> <h3>Before taking NERLYNX, tell your healthcare provider about all of your medical conditions, including if you:</h3> <ul> <li>Have liver problems. You may need a lower dose of NERLYNX.</li> <li> Are pregnant or plan to become pregnant. NERLYNX can harm your unborn baby. If you are a female who can become pregnant: <ul> <li>Your healthcare provider should do a pregnancy test before you start taking NERLYNX.</li> <li>You should use effective birth control (contraception) during treatment and for at least 1 month after your last dose of NERLYNX.</li> <li>Talk with your healthcare provider about forms of birth control that you can use during this time.</li> <li>Tell your healthcare provider right away if you become pregnant during treatment with NERLYNX.</li> <li>Males with female partners who can become pregnant should use effective birth control during treatment and for 3 months after the last dose of NERLYNX.</li> </ul> </li> <li>Are breastfeeding or plan to breastfeed. It is not known if NERLYNX passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after your last dose of NERLYNX.</li> </ul> <p><b>Tell your healthcare provider about all the medicines you take,</b> including prescription and over-the-counter medicines, vitamins, and herbal supplements.</p> <h3><b>Especially tell your healthcare provider if</b> you take medicines used to decrease stomach acid, called proton pump inhibitors or PPIs. You should avoid taking these medicines during treatment with NERLYNX.</h3> <h3>What should I avoid while taking NERLYNX?</h3> <p>You should avoid eating products that contain grapefruit during treatment with NERLYNX.</p> <h2 id="side-effects">What are the possible side effects of NERLYNX?</h2> <p><b>NERLYNX may cause serious side effects, including</b>:</p> <p> See <a href="#important-info"></a><b>"What is the most important information I should know about NERLYNX?"</b> </p> <ul> <li> Liver problems. Changes in liver function tests are common with NERLYNX. Your healthcare provider should do blood tests before you begin treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. Your healthcare provider will stop your treatment with NERLYNX if your liver tests show severe problems. Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: <ul> <li>Tiredness</li> <li>Nausea</li> <li>Vomiting</li> <li>Pain in the right upper stomach-area (abdomen)</li> <li>Fever</li> <li>Rash</li> <li>Itching</li> <li>Yellowing of your skin or whites of your eyes</li> </ul> </li> </ul> <p><b>The most common side effects</b> of NERLYNX when used alone include:</p> <ul> <li>Diarrhea</li> <li>Nausea</li> <li>Stomach-area (abdomen) pain</li> <li>Tiredness</li> <li>Vomiting</li> <li>Rash</li> <li>Dry or inflamed mouth, or mouth sores</li> <li>Decreased appetite</li> <li>Muscle spasms</li> <li>Upset stomach</li> <li>Nail problems including color change</li> <li>Dry skin</li> <li>Swelling of your stomach-area</li> <li>Nosebleed</li> <li>Weight loss</li> <li>Urinary tract infection</li> </ul> <p><b>The most common side effects</b> of NERLYNX when used with capecitabine include:</p> <ul> <li>Diarrhea</li> <li>Nausea</li> <li>Vomiting</li> <li>Decreased appetite</li> <li>Constipation</li> <li>Tiredness/weakness</li> <li>Weight loss</li> <li>Dizziness</li> <li>Back pain</li> <li>Joint pain</li> <li>Urinary tract infection</li> <li>Upper respiratory tract infection</li> <li>Swelling of your stomach-area</li> <li>Kidney problems</li> <li>Muscle spasms</li> </ul> <p>These are not all of the possible side effects of NERLYNX. For more information, ask your Healthcare Provider.</p> <p>Tell your healthcare provider if you have any side effects that bother you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.</p> <p>Please see <a href="https://nerlynx.com/pdf/nerlynx_product_information_download.pdf" target="_blank">Patient Information</a>.</p> </div> </div> </div> </section>  <button type="button" class="back-top" data-goto=".wrapper"> <div class="back-top__icon"><svg width="18" height="18"> <use xlink:href="../img/icons/icons-new.svg#svg-arrow-up-solid"></use> </svg></div> <span class="back-top__text">Back to top</span> </button> </main> <footer class="footer"> <div class="footer__container"> <div class="footer__top"> <div class="footer__info"> <a href="../index.html" class="footer__logo" ><picture ><source srcset="../img/logo.webp" type="image/webp" /> <img src="../img/logo.png" width="140" height="48" alt="Puma Biotechnology, Inc." /></picture ></a> <div class="footer__col"> <h3 class="footer__label">About Us</h3> <ul class="footer__menu"> <li class="footer__item-menu"><a href="../about/overview.html">Overview</a></li> <li class="footer__item-menu"><a href="../about/leadership.html">Leadership team</a></li> <li class="footer__item-menu"><a href="../about/bod.html">Board of Directors</a></li> <li class="footer__item-menu"><a href="../about/cg.html">Corporate Governance</a></li> </ul> </div> </div> <div class="footer__social"> <h3 class="footer__label">Get in touch</h3> <ul class="footer__social-list"> <li class="footer__social-item"> <a href="#" aria-label="Follow us on LinkedIn" data-popup=".third-website" data-popup-redirect="https://www.linkedin.com/company/puma-biotechnology-ltd" target="_blank"><svg width="30" height="30"> <use xlink:href="../img/icons/icons-new.svg#svg-linkedin-brands-solid"></use> </svg></a> </li> </ul> </div> </div> <div class="footer__contacts" data-da=".footer__top, 768, 1"> <h3 class="footer__label">Contact</h3> <div class="footer__line"> <div class="footer__row"> <h4 class="footer__caption">Puma Biotechnology, Inc.</h4> <p> Los Angeles, California <br /> 424-248-6500 Main </p> </div> <div class="footer__row"> <h4 class="footer__caption">Medical Information:</h4> 1-844-MED-PUMA (1-844-633-7862), or <br /> <a href="mailto:medinfo@pumabiotechnology.com">medinfo@pumabiotechnology.com</a> </div> <div class="footer__row"> <h4 class="footer__caption">Business Development:</h4> <p> <a href="mailto:info@pumabiotechnology.com">info@pumabiotechnology.com</a> </p> </div> <div class="footer__row"> <h4 class="footer__caption">investor Relations:</h4> <a href="mailto:ir@pumabiotechnology.com">ir@pumabiotechnology.com</a> </div> </div> </div> <div class="footer__bottom"> <p class="footer__copyright">© 2025 Puma Biotechnology, Inc.</p> <ul class="footer__menu footer__menu--row"> <li class="footer__item-menu"><a href="../privacy-policy.html">Privacy Policy</a></li> <li class="footer__item-menu"><a href="../wa-pp.html">WA Privacy Policy</a></li> <li class="footer__item-menu"><a href="../tos.html">Terms of Service</a></li> <li class="footer__item-menu"><a href="../data-rights-request.html">Data Rights Request</a></li> <li class="footer__item-menu"><a href="../legal-notice.html">Legal Notices</a></li> <li class="footer__item-menu"><a href="../site-map.html">Site Map</a></li> </ul> </div> </div> </footer> </div> <div id="popup" aria-hidden="true" class="popup third-website"> <div class="popup__wrapper"> <div class="popup__content"> <button data-close type="button" class="popup__close">Close</button> <div class="popup__text"> <h3>NOTICE: You are leaving our website</h3> <p> When you click on the button below, you will leave our website and will enter a website maintained by a third party that is not related to Puma Biotechnology, Inc. 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