FDA approves Pfizer’s Vizimpro for non-small cell lung cancer
Pfizer has received the green light from the Food and Drug Administration (FDA) for Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
“Improving outcomes for patients is the central focus of why we develop and deliver new medicines. Vizimpro is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” Pfizer oncology global president Andy Schmeltz said, in a press statement. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”
“EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” primary investigator for the ARCHER 1050 study and chair of the department of clinical oncology, The Chinese University of Hong Kong Tony Mok said, in a statement. “The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.”
“Today’s approval of Vizimpro is a direct result of our commitment to precision drug development and improving outcomes for patients with mutation-driven lung cancers. Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer: Xalkori for patients with ALK-positive or ROS1-positive non-small cell lung cancer and Vizimpro for patients with EGFR-mutated non-small cell lung cancer,” Pfizer global product development, chief development officer oncology Mace Rothenberg said, in a statement.
FDA OKs expanded indication for Gardasil 9
The Food and Drug Administration has approved the expanded the use of Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), to include women and men aged 27 years old through 45 years old. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck Sharp & Dohme, a subsidiary of Merck.
“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” FDA’s Center for Biologics Evaluation and Research director Peter Marks said in a statement. “The Centers for Disease Control and Prevention has stated that HPV vaccination, prior to becoming infected with the HPV types covered by the vaccine, has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing.”
According to the Centers for Disease Control and Prevention, roughly 14 million Americans annually become infected with HPV. Roughly 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses.
Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.
Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the United States. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 years old through 26 years old.
The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.
Teva’s Ajovy for migraine gets FDA green light
Teva Pharmaceutical Industries has received clearance from the Food and Drug Administration for Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults.
“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,”Stephen Silberstein, Jefferson Headache Center director at Thomas Jefferson University Hospital and lead investigator of Phase III clinical trial program at Ajovy, said. “About 40% of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”
Ajovy, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly 675 mg, and monthly 225 mg dosing options, according to the company.
“This is an important day for Teva, and complements our long-standing history of helping patients living with diseases of the central nervous system,” Teva president and CEO Kare Schultz said. “The approval of Ajovy helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders — patients, employees and shareholders.”
“With limited availability of preventive treatment options, Ajovy provides physicians with an important new option for their patients,” Teva executive vice president, global R&D Hafrun Fridriksdottir said. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”
“Today’s approval is an important step forward for Teva and the migraine community,” Teva executive vice president and head of North America Commercial Brendan O’Grady said.“Our entire organization is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much-needed category.”