Faster FDA Spurs Cancer Breakthroughs

“More new drugs are getting the green light in the U.S. as drugmakers take advantage of a speedier metabolism at the Food and Drug Administration.

“Through March 19, the FDA has approved 10 new drugs, on pace to match last year’s total of 41, which was an 18-year high.

“The agency is moving faster partly because of 2012 mandates from Congress, analysts and industry executives say. That is spreading investor and drugmaker optimism by boosting innovative drugs that promise the biggest benefit.

“This year’s approvals include the first medicine in years for initial treatment of a common form of advanced breast cancer. On March 15, researchers published data showing two medications that could hit the market this summer may cut heart attacks and other cardiac events in half for patients with high cholesterol.”


Opdivo Approved for Squamous Lung Cancer

“Bristol-Myers Squibb (BMY) secured an expanded U.S. approval Wednesday for the use of its checkpoint inhibitor Opdivo to treat a form of advanced lung cancer.

“The new Opdivo approval covers patients with squamous non-small cell lung cancer no longer responsive to chemotherapy, according to an announcement made by the FDA. In December, Bristol’s drug was approved initially to treat skin cancer.

“The FDA moved exceptionally fast expanding Opdivo’s approval. Bristol said the lung cancer application was accepted last week with an approval decision expected in June.

“The worldwide commercial market for squamous cell lung cancer patients tops $3 billion, according to an analysis by Barclays.”


U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (Nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

“Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab)for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.

“In the U.S., lung cancer is one of the leading causes of cancer deaths. Non-small cell lung cancer, one of the most common types accounting for approximately 85 percent of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30 percent of all lung cancers.

“ ‘With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,’ said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb. ‘As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.’ ”


FDA to Review Treatment Injected into Metastatic Melanoma Tumors

The gist: A treatment for metastatic melanoma called talimogene laherparepvec (T-VEC) will soon be reviewed by the FDA for treating patients with metastatic melanoma. If T-VEC is approved, doctors in the U.S. will be free to prescribe it to their patients. T-VEC is an immune system-boosting treatment that is injected directly into melanoma tumors. Learn more about it in this Need to Know blog post.

“Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company’s Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.

” ‘The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need,’ said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. ‘We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA.’ “


FDA Approves High-Tech Breast Imaging System

“After more than a decade of development and data-gathering—including breast scans on nearly 700 women and 79 patents issued—the U.S. Food and Drug Administration has approved a breast-cancer imaging system invented by a University of Rochester Medical Center professor.

“FDA approval of the breast scanner is the latest in a long line of URMC technologies that have been licensed and marketed, including cancer and pediatric vaccines.

“The professor, Ruola Ning, Ph.D., is president and founder of Koning Corporation, a URMC startup company. The FDA’s action allows Koning to begin commercial distribution of its Koning Breast CT (KBCT) system. Koning’s medical device passed the FDA’s most stringent premarket approval process, which requires extensive clinical study.

“Currently, the KBCT is not intended to be used for breast cancer screening, or to replace mammography. It is for diagnosing cancer in women who have signs or symptoms of the disease, or who have abnormal findings after a standard screening mammogram. For these more complex cases, the KBCT was found to be safe and effective for diagnostic use.”


FDA Approves Palbociclib/Ibrance for HER2-Negative, Advanced Breast Cancer

“Federal health regulators on Tuesday approved a highly anticipated medicine from Pfizer Inc. to treat postmenopausal women with a certain type of advanced breast cancer who have not already taken other drugs.

“The Food and Drug Administration approved Ibrance for women who have tumors that do not contain a protein known as HER-2. Ibrance, known generically as palbociclib, works by blocking molecules linked to .

“Pharmaceutical industry analysts expect Ibrance to grow into a mega-blockbuster, with annual sales as high as $4 billion by 2020.

“The drug is intended to be used in combination with another cancer medication known generically as letrozole.

“The FDA granted the drug accelerated approval—more than two months ahead of its April 13 target date—based on a 165-patient study showing that it slowed the progression of . Patients taking Ibrance and letrozole lived 20.2 months on average before their tumors worsened. That was about twice as long as the benefit for women in a comparison group who only received letrozole. The study is ongoing and it’s not yet clear whether Ibrance’s benefits result in increased survival times for patients.”


The Role of Pertuzumab in Treating HER2+ Breast Cancer


Pertuzumab (Perjeta) is a relatively new drug that targets HER2, a protein found at higher-than-normal levels in about 15% to 20% of all breast cancers. Too much HER2 leads to tumor growth. Currently, all newly diagnosed breast cancer patients have their tumors’ HER2 levels tested. Knowing whether a patient’s HER2 levels are abnormally high (HER2-positive) or normal (HER2-negative) is a major factor in choosing a treatment, thanks to the availability of trastuzumab (Herceptin) and, now, other HER2-targeted drugs such as Perjeta, T-DM1 (Kadcyla), and lapatinib (Tykerb). These drugs are all used to treat HER2-positive patients. Continue reading…


FDA Has Not Yet Planned Meeting to Evaluate Palbociclib for Postmenopausal Women with Advanced ER+ HER2- Breast Cancer

The gist: In October, the U.S. Food and Drug Administration (FDA) announced that it had granted Priority Review to new breast cancer drug palbociclib, meaning that it would speed its review process to get the drug to more patients sooner. However, as of January 2015, the FDA has not yet planned a meeting to evaluate the drug. The reason for the delay has not been announced. Palbociclib has shown promise for postmenopausal women with advanced, ER-positive, HER2-negative breast cancer. If it is approved by the FDA, doctors across the U.S. will be able to prescribe palbociclib to these patients.

“The U.S. Food and Drug Administration isn’t planning an advisory committee meeting at this time to evaluate Pfizer Inc.’s experimental breast-cancer treatment, despite the drug having received priority-review status in October, the company said Thursday.

“Pfizer didn’t provide reasons for the delay, but said it continues to talk with the FDA about the application for palbociclib, also known by the brand name Ibrance.

“An FDA spokesperson wasn’t immediately available to respond.

“The drug is one of many experimental therapies that targets certain proteins in the body known as CDKs. Cancer hijacks these proteins to help tumor cells grow. Recent studies suggest that stopping these proteins can help stall cancer.”


FDA Approves Granix Injection for Self-Administration in Patients with Severe Neutropenia

The gist: Doctors in the U.S. are now free to prescribe a treatment for severe neutropenia that patients can give to themselves at home. The treatment is called Granix. Being able to inject Granix at home could help patients reduce the number of visits to the doctor’s office. Neutropenia is a condition in which a patient has a lower-than-normal number of white blood cells in their bloodstream. It is a side effect of some cancer treatments.

“The FDA has approved a self-administered injection of the leukocyte growth factor tbo-filgrastim for patients with nonmyeloid malignancies, allowing more flexibility for physicians to prescribe the drug for in-office or at-home use, the drug’s manufacturer announced.

“Tbo-filgrastim (Granix, Teva Pharmaceuticals), which has been commercially available in the US since November, 2013, has been indicated to allow for the marketing of a new syringe that can be administered either by the patient or a caregiver without having to visit the physician’s office.

“ ‘In partnership with their physician, patients will be able to decide whether administering Granix via self-injection at home or by a healthcare professional is the right course for them,’ Lee S. Schwartzberg, MD, FACP, division chief of hematology oncology at the University of Tennessee Health Science Center, Knoxville, Tenn., said in a statement released by Teva. ‘Selecting a course of self-administration may allow patients to consolidate the number of required visits to their physician and allow additional access for patients who have challenges in visiting their providers.’ ”