Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting

“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “


FDA Assigns Sacituzumab Govitecan Breakthrough Designation for TNBC

“The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.

“The designation, which will expedite the development and review of sacituzumab govitecan in TNBC, is based on a phase II trial in which the therapy induced a response rate of 31% in heavily pretreated patients with metastatic TNBC.

“ ‘We believe breakthrough therapy designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,’ Cynthia L. Sullivan, president and chief executive officer, of Immunomedics, said in a statement. ‘We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the special protocol assessment agreement that was already granted by the FDA,’ she added.”


FDA Grants Orphan Drug Designation to IMCgp100 for Uveal Melanoma

“The FDA granted orphan drug designation to IMCgp100 for the treatment of uveal melanoma.

“IMCgp100 (Immunocore) is part of a class of bispecific biologic reagents known as ImmTACs, or immune-mobilizing monoclonal T-cell receptors against cancer.

“The agents combine a T-cell receptor-based targeting system with an anti-CD3 effector function designed to activate a specific and potent T-cell response to recognize and destroy cancer cells, according to Immunocore.”


FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

“The FDA has expanded the approval for single-agent pembrolizumab (Keytruda) to include the frontline treatment of patients with advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial.

“In the study, which compared 2 pembrolizumab regimens with ipilimumab, the PD-1 inhibitor reduced the risk of disease progression by >40% and the risk of death by >30%.

“ ‘As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,’ Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the developer of the PD-1 inhibitor, said in a statement. ‘Today’s news is another exciting milestone for Keytruda and for patients with this disease.’ “


Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”


FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumors in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60 percent of people (CNS ORR of 61 percent [95 percent CI 46-74]).”


FDA Grants Priority Review to Xalkori for New Indication in NSCLC

“The FDA granted priority review to a supplemental new drug application for crizotinib.

“Crizotinib (Xalkori, Pfizer) — a kinase inhibitor — already is approved for treatment of patients with metastatic ALK-positive non–small cell lung cancer.

“The supplemental application requests that the approval be expanded to allow crizotinib to be used for treatment of patients with metastatic ROS1-positive NSCLC. The FDA granted breakthrough therapy designation to crizotinib for this indication in April.

“ROS1 rearrangement occurs in an estimated 1% of NSCLC cases, according to a Pfizer-issued press release.”


Crizotinib Granted FDA Priority Review for ROS1 mNSCLC

“The FDA has granted a priority review for a supplemental new drug application (sNDA) for crizotinib (Xalkori). The application is for an indication in patients with metastatic non–small cell lung cancer (NSCLC), whose tumors are ROS1-positive, according to a press release posted by Pfizer Inc.

” ‘ROS1 is another gene rearrangement. It is like ALK in that it is structurally related, but rarer. ROS1 occurs in about 1% of [NSCLC] patients, but [it has] also been seen in other types of rare cancers,’ said D. Ross Camidge, MD, PhD, director, Thoracic Oncology Clinical Program, University of Colorado Cancer Center, in an interview with Targeted Oncology. He added that crizotinib, originally an ALK inhibitor, may be even more effective as a ROS1 inhibitor. ‘It’s great for that small population of patients.’ “


FDA Approves Ablatherm HIFU Treatment for Prostate Cancer

“The FDA has fully approved the Ablatherm high-intensity focused ultrasound device for the nonsurgical and noninvasive treatment of localized prostate cancer, according to a press release from the device’s manufacturer.

“Ablatherm high-intensity focused ultrasound (EDAP TMS), or Ablatherm HIFU, is recommended for men with localized prostate cancer (stages T1-T2) who are not candidates for surgery, who prefer an alternative option or who failed radiotherapy treatment.

“The device targets the tumor via a computer-controlled rectal probe. Ultrasound waves are intended to destroy the prostate tissue while sparing surrounding organs. Data have indicated the device is effective for prostatic tissue ablation with a low occurrence of side effects, according to the press release.”