In This Article
- Zejula Now Approved for Late-Line Ovarian Cancer
- Trump Set to Nominate Hahn as FDA Commissioner
- FDA Aims to Improve Breast Implant Guidance
Zejula Now Approved for Late-Line Ovarian Cancer
On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment of adult patients with advanced homologous recombination deficiency−positive ovarian, fallopian tube, or primary peritoneal cancer who have received ≥3 previous lines of chemotherapy. Homologous recombination deficiency−positive status is defined by a deleterious or suspected deleterious BRCA mutation, or genomic instability and disease progression >6 months after response to the last platinum-based chemotherapy.
This is an expanded indication for niraparib, which was originally approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
This new indication is based on results of the phase 2 multicenter, open-label, single-arm QUADRA clinical trial. Efficacy outcomes were measured in 98 patients with advanced ovarian cancer with homologous recombination deficiency−positive tumors as determined by a companion diagnostic, Myriad Genetics’ myChoice CDx, which was also FDA approved on October 23, 2019. Treatment with niraparib elicited an overall response rate of 24% (all of which were partial responses) and an estimated median duration of response of 8.3 months.
Adverse reactions in the QUADRA trial led to dose reduction or interruption in 73% of patients receiving niraparib. The most common adverse reactions (>5%) resulting in dose reduction or interruption were thrombocytopenia (40%), anemia (21%), neutropenia (11%), nausea (13%), vomiting (11%), fatigue (9%), and abdominal pain (5%).
Approximately 22,000 women are diagnosed with ovarian cancer in the United States each year. There are limited late-line treatment options if their cancer recurs after initial chemotherapy.
“Ovarian cancer has a high rate of recurrence, so there is a real need for therapies for women whose cancer has progressed through multiple lines of treatment and who have few or no options left,” said QUADRA’s lead investigator, Kathleen Moore, MD, Director, Oklahoma TSET Phase 1 Program, Associate Professor, Section of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma. “It’s meaningful to see that Zejula has been approved as a late-line treatment for women including those with and without BRCA mutations.”
Trump Set to Nominate Hahn as FDA Commissioner
Earlier this month, news outlets began reporting that Stephen M. Hahn, MD, FASTRO, Chief Medical Executive, The University of Texas M.D. Anderson Cancer Center, Houston, would likely replace Norman “Ned” Sharpless, MD, Acting FDA Commissioner, at the end of Dr Sharpless’s temporary term, which expires on November 1, 2019. At the time, the story had not been confirmed by the White House. Now, as Dr Sharpless’s term nears its expiration date, the issue is again receiving attention, although Dr Hahn has yet to be officially nominated by the president. If nominated, he will have to pass a background check and be confirmed by the US Senate—a process that could take months—before officially stepping into the role as the permanent commissioner.
Dr Sharpless has held the position of Acting Commissioner since Scott Gottlieb, MD, unexpectedly stepped down in March 2019. During his brief tenure, Dr Gottlieb was recognized for making significant strides toward several goals. Under his leadership, the FDA delivered a record number of approvals of innovative therapies and generic drugs, and took a stand on such issues as vaping, the opioid crisis, and others.
In the past few days, rumors again began circulating that Dr Hahn’s nomination was imminent, and the news has been widely reported as a near certainty. However, the nomination is not without some controversy. As The Washington Post and other news outlets have reported, Dr Sharpless was regarded by many individuals, including Dr Gottlieb, as the preferred choice to lead the FDA. If Dr Hahn is appointed, it is believed that Dr Sharpless will return to the National Cancer Institute, where he was Director before beginning his term as Acting FDA Commissioner.
FDA Aims to Improve Breast Implant Guidance
Following a public advisory meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in March 2019, the FDA has released draft guidance aimed at ensuring that women have access to important information regarding the risks and benefits of breast implants.
Among the topics discussed at the meeting were breast implant−associated anaplastic large-cell lymphoma; systemic symptoms reported in patients receiving breast implants (known as breast implant illness); and best practices for informed consent discussions between patients and clinicians.
According to an FDA press release, the agency heard “loud and clear” that women and other stakeholders believe that they need more information about the risks associated with breast implants before they make the decision to undergo the procedure, and the draft guidance includes several recommendations to that end.
Among the proposed recommendations, which are not mandatory and are open to public comment and inquiry, are the inclusion of boxed warnings on device labels and a standardized checklist as part of the informed consent process.
Breast augmentation is the most frequently performed cosmetic surgical procedure in the United States, and the FDA has taken steps to inform all stakeholders and patients of the associated risks, including recently requesting that one manufacturer recall its textured breast implant devices from the market because of the risk for breast implant−associated anaplastic large-cell lymphoma. The agency has acknowledged, however, that there “is a distinct opportunity to do more to protect women who are considering breast implants.”