Last month, Swiss drug maker Roche Holding AG reported the discovery of a drug, trastuzumab-DM1 (T-DM1), the first conjugated monoclonal antibody that has proven to shrink tumors in HER2-positive breast cancer patients, and announced filing an application with the Food and Drug Administration (FDA) for approval based on Phase II studies while continuing Phase III studies.
The particular characteristic of HER2-positive breast cancer is a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells, affecting about 20% of breast cancers. The cancer cells make an excess of HER2 due to a gene mutation.
Excited that a new treatment could soon be available based on the Phase II trials which revealed that T-DM1 shrank tumors in HER2 breast cancer patients, Hal Barron, Chief Medical Officer, Roche had hopes the drug’s lauch could take place early in 2011.
That hope was squashed this week, however, as the FDA determined that the supporting data for TDM1 did not meet the Biologic License Application (BLA) Standard for accelerated approval because all available treatment choices for metastic breast cancer – irrespective of HER2 status – had not been exhausted.
Undeterred, Barron said, “We firmly believe in the potential of T-DM1 as a novel HER2 targeted option and remain fully committed to its ongoing development.”
Roche stated in a media release, “Roche will submit the data from the amended Phase III randomized EMILIA study to support a global regulatory submission in mid 2012. The EMILIA study compares T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2 positive breast cancer whose disease has worsened after receiving initial treatment.”
A global regulatory submission by Roche is expected mid 2012.
Cancer survivors are among the most courageous warriors who are literally fighting for their lives. None are more courageous, stong, generous or supportive than breast cancer survivors.
After her mastectomy, Debra asked her doctor, “when am I considered to be a survivor?” Anita Minghini, MD, Surgeon, Winchester Breast Center, VA replied, “You became a survivor the moment you heard your diagnosis and decided to fight; you have been surviving since that day.”
News of a breast cancer diagnosis causes a wide variety of emotions and can be a heart-stopping event as your mind and emotions race from one end of the spectrum to the other while your doctor explains the details of the cancer and what the next steps are.
Building a strong support network of family, friends, co-workers and cancer survivors is imperative as you begin your journey to fight breast cancer. Family, friends, health care providers all are considered co-survivors as they support you through listening, talking, gathering information, helping with day to day tasks, help you make decisions from diagnosis through treatment and beyond.
Building a relationship of trust and confidence in your doctor starts with talking to him or her about your feelings, fears and questions. This relationship will help you work together to make important treatment decisions.
The Susan J Komen Foundation website offers a plethora of information regarding all aspects of the journey from diagnosis through treatment and survival. Personal stories from actual breast cancer survivors in different stages of their journey are insightful and offer hope to anyone dealing with the disease.
In her story on the Komen website, Valerie Wilson recalls her first thoughts as being, “I’m going to die,” when she received a diagnosis of invasive carcinoma breast cancer in 1993. Remembering the devastation of the news, she “prayed to God for guidance, strength and healing”. Thoughts of Minnie Ripperton, a famous singer who died from breast cancer by refusing to have a mammogram, she describes her “dreams of being a singer were shattered”.
Wilson’s story is not over she says, ” I am a 13-year survivor and in the best health yet! I haven’t given up my personal dreams or my resolve to battle breast cancer. ”
Breast cancer is not a respector of persons, as it strikes mothers, grandmothers, sisters, daughters, rich, poor, overweight and underweight individuals.
A short synopsis from Kristine Taylors story: when she found a bump in each of her brests in February 2010, she went to her obstetrician who, “gave me a referral to get an ultrasound. She told me it was probably my implants as I didn’t fit the profile of breast cancer. The ultrasound showed that the lumps were the valves from my implants, but it also showed something that didn’t look right so they did a mammogram. Nothing showed with the mammogram, so they did a more extensive ultrasound and decided to do a biopsy. ”
Soon after, the pathology report revealed breast cancer, catapulting Kristine into investigating all she could discover about the disease. Finding that she had the BRAC gene, she chose to have a bilateral mastectomy. Believing her cancer to be Stage I based on MRI, Taylor and her oncologist expected there to be no need for chemo or radiation.