Coming treatments: Pfizer's Palbociclib

['lizbeth]

Although this is in trials for Er+ Her2- it is one to watch for breast cancer.

Palbociclib (PD-0332991)

Target: Inhibitor of cyclin-dependent kinases (CDK) 4 and 6
Disease focus: Metastatic breast cancer
Developer: Pfizer ($PFE)

Palbociclib has shown powerful effects in women with a common molecular form of metastatic breast cancer, prompting industry watchers to pump up the market potential of the oral agent. Pfizer CEO Ian Read has trumpeted the inhibitor of CDK 4 and 6 as a leading late-stage contender in the drug giant's resurgent R&D pipeline, and the FDA designated the compound as a "Breakthrough Therapy" with all the speedy development and review benefits of the status in April.

Breast cancer is the leading cause of cancer death in women. A variety of molecular drivers make breast cancer a heterogeneous disease, yet Pfizer investigators have found impressive evidence of efficacy for palbociclib in postmenopausal women with an ER-positive, HER2-negative form of the cancer. This molecular makeup represents 60% of postmenopausal cases of aggressive or metastatic breast cancer, making it the largest subgroup in this diverse population of cancer patients.

In December investigators impressed analysts with interim Phase II data that showed how breast cancer patients on palbociclib and Novartis' ($NVS) standard antihormone therapy Femara went more than 18 months longer without their disease worsening compared with patients on Femara alone. Based on the signs of efficacy against the major illness, Citigroup's Andrew Baum estimated potential annual sales of $5 billion. Yet industry watchers await full data from the study and evidence of improved overall survival, the true mark of a breakthrough.

With palbociclib, Pfizer is forging ahead in an area of oncology drug development with few successes. The drug targets two triggers in the tumor cell cycle to stymie development of cancer cells before DNA replication and cell division. Eli Lilly ($LLY) has a CDK 4/6 inhibitor of its own called LY2835219 in early stage development for advanced tumors and a Phase II study in patients with mantle cell lymphoma.

Pfizer has engineered a wide-ranging development program to study palbociclib for patients with a variety of cancers, some of which include ovarian cancer, multiple myeloma and acute lymphoblastic leukemia.

For more:
FDA stokes blockbuster hopes with 'breakthrough' brand for Pfizer cancer drug
Pfizer seeks inside track at FDA for blockbuster breast-cancer hopeful
Pfizer eyes PhIII with impressive data for breast-cancer fighter

['lizbeth]

HER2 Positive Breast Cancer Drug Market to 2023: US, China and Japan Analysis With Forecasts


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DALLAS, October 22, 2014 /PRNewswire/ --

RnRMarketResearch.com adds PharmaPoint: HER2-Positive Breast Cancer - Drug Forecast and Market Analysis to 2023 research reports for United States (US), China and Japan to the cancer drugs market research collection of its online library.

The PharmaPoint: HER2-Positive Breast Cancer - China Drug Forecast and Market Analysis to 2023 says currently, treatment rates for HER2-positive breast cancer in China are low, with Roche reporting that approximately 30% of patients diagnosed with the disease actually received a treatment that contained an HER2-targeting therapy in 2013. Similar report on US HER2 positive breast cancer drug market says that the high incidence of HER2-positive breast cancer in the US, almost equaling that of the entire 5EU, and the high treatment rates in the neoadjuvant and adjuvant settings using HER2-targeted therapies in all stages, have helped drive the sales of HER2-positive therapeutics in the US. HER2-targeting therapies are priced at a premium in the US, owing to the country's private health insurance system, which can most easily afford to reimburse the latest expensive drugs.

HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. These reports focus on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-positive breast cancer market, with coverage of multiple settings of the disease including neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic. In 2013, Herceptin was the market leader, taking 92% of the Japanese HER2 positive breast cancer drug market. This is due to the fact that it is the most established agent in this disease and is used in all settings, although over half of all Herceptin use is in the adjuvant setting.

Competitive assessment chapters of these HER2-positive breast cancer drug market reports provide product profiles for HER2 Targeted Therapies of Herceptin (trastuzumab), Tykerb (lapatinib), Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine, T-DM1). Product profiles of general targeted therapies covered in these researches include Afinitor (everolimus), Xeloda (capecitabine), Avastin (bevacizumab), Halaven (eribulin mesylate) and Abraxane (nab-paclitaxel). Hormonal agents like Tamoxifen, Faslodex (fulvestrant) and Aromatase Inhibitors are also discussed. Under the pipeline assessment section of these reports, promising drugs in clinical development discussed include Gilotrif (afatinib) and Neratinib whereas promising drugs in early-stage development like Palbociclib, NeuVax (nelipepimut-S), Patritumab, Ganetespib, ARRY-380 (ONT-380) and NVP-BYL719 are also discussed.

Scope of these regional HER2-positive breast cancer drug market reports cover: An overview of HER2-Positive Breast Cancer, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines. Annualized HER2-Positive Breast Cancer market revenue and future forecasts from 2011 to 2013, forecast for 7 years to 2020 for Japan, US and China. Investigation of current and future market competition for HER2-Positive Breast Cancer. Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events. Competitor assessment including device approval analysis and device sales forecasts. Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast. Analysis of unmet needs within the market and opportunities for future players. Technology trends evaluation to assess strength of pipeline. An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines. Company profiles including business description, financial overview and SWOT analysis. Coverage of key market players. Strategic assessment of the HER2-Positive Breast Cancer sector through market impact analysis, future market scenario and company analysis. Direct quotes from Key Opinion Leaders (KOL) as well as doctors.