Novartis Takes Fight to Pfizer’s Ibrance with New Kisqali Data

Excerpt:

“New data from Novartis’s breast cancer drug Kisqali underscored its effectiveness in pre-menopausal women, the Swiss drugmaker said, amid efforts to muscle in on turf dominated by rival Pfizer’s Ibrance.

“A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone, Novartis said on Wednesday.”

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New SERM Shows Promise in Advanced Breast Cancer

Excerpt:

“In women with estrogen receptor-positive, hormone-refractory metastatic breast cancer, oral Z-endoxifen hydrochloride, the potent metabolite of tamoxifen, provided substantial drug exposure regardless of CYP2D6 genotype, acceptable toxicity, and promising antitumor activity, researchers reported.

“Results from a phase I study in 38 patients with metastatic breast cancer demonstrated a clinical benefit rate (stable disease ≥ 6 months) of 26.3%. including a partial response by RECIST criteria in three patients who experienced progression during prior tamoxifen therapy, according to Matthew P. Goetz, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.”

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Breast Cancer Patients Forego Post-Surgery Treatment Due to Mistrust, Study Suggests

Excerpt:

“Nearly one-third of women with breast cancer went against their doctor’s advice and chose not to begin or complete the recommended adjuvant anti-cancer therapy to kill residual tumor cells following surgery, according to a study led by a Johns Hopkins Bloomberg School of Public Health researcher.

“A survey that included 2,754 breast cancer patients in Florida and Pennsylvania during a two-year period found that this ‘treatment discordance’ – not following a doctor’s recommended treatment plan in its entirety – was more likely among patients who reported a general distrust of medical institutions and insurers. The patients’ trust or distrust of their own doctors did not seem to be a factor.”

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Expert Raises QoL Concerns With Adjuvant Hormonal Therapy in ER+ Breast Cancer

Excerpt:

“As research of early-stage estrogen receptor (ER)-positive breast cancer continues, experts are relying more on extended adjuvant hormonal therapy with aromatase inhibitors, but are concerned about patient quality of life (QoL) with such treatment.

” ‘My passion is to really try to figure out how to make the side effects of these therapies more tolerable and how to help women be able to actually have reasonably good and normal QoL while they’re taking these therapies, so that we can increase compliance,’ said Michelle E. Melisko, MD.”

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FDA Grants Fast Track Designation to Elacestrant for Breast Cancer Subtype

Excerpt:

“The FDA granted fast track designation to elacestrant for the treatment of ER-positive, HER-2-negative advanced or metastatic breast cancer, according to the drug’s manufacturer.

“Elacestrant (RAD1901, Radius Health) an investigational oral selective ER downregulator/degrader is under investigation as a nonsteroidal treatment for hormone-driven or hormone-resistant breast cancer.”

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Astra and Merck Win Speedy Review for Lynparza in Breast Cancer

Excerpt:

“U.S. regulators have granted a priority review to AstraZeneca’s ovarian cancer drug Lynparza as a treatment for breast cancer, putting it on track for potential approval in the new disease area during the first quarter of 2018.

“The medicine, which is being jointly developed and marketed with Merck under a deal struck in July, is the first poly ADP-ribose polymerase (PARP) drug to be considered for use outside ovarian cancer.”

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Dual HER2 Blockade Alone Yields Worse pCR in Early HER2-Positive Breast Cancer

Excerpt:

“A new randomized trial found that neoadjuvant trastuzumab/pertuzumab alone yields a substantially worse rate of pathologic complete response compared with trastuzumab/pertuzumab plus paclitaxel in women with early, HER2-positive, hormone receptor (HR)-negative breast cancer.

” ‘Pathologic complete response (pCR) after neoadjuvant [therapy] has strong prognostic impact in HER2 disease,’ wrote study authors led by Ulrike Nitz, MD, of the West German Study Group GmbH in Moenchengladbach, Germany. The WSG-ADAPT HER2+/HR− trial assessed whether dual blockade with trastuzumab and pertuzumab could achieve similar rates of pCR in those with strong early response to dual blockade along with chemotherapy.”

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Cryotherapy for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Breast Cancer

Excerpt:

“A self-controlled clinical trial by Hanai et al investigating the efficacy of cryotherapy for the prevention of chemotherapy-induced peripheral neuropathy in patients with breast cancer treated with paclitaxel has found that cryotherapy resulted in a clinically and statistically significant reduction in patient-reported subjective symptoms, diminished objective signs (tactile and thermosensory), and prevention of manipulative dexterity. These study findings suggest cryotherapy may be an effective strategy in the prevention of neuropathy in patients undergoing paclitaxel treatment. These study findings were published in the Journal of the National Cancer Institute.

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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

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