SILVER
SPRING, Md., May 17, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration
is providing an at-a-glance summary of news from around the
agency:
- On Thursday, the FDA granted accelerated approval to
tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small
cell lung cancer (ES-SCLC) with disease progression on or after
platinum-based chemotherapy. The prescribing information for
tarlatamab-dlle includes a Boxed Warning for serious or
life-threatening cytokine release syndrome (CRS) and neurologic
toxicity, including immune effector cell-associated neurotoxicity
syndrome (ICANS). The most common adverse reactions (>20%) were
cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia,
decreased appetite, musculoskeletal pain, and constipation, anemia
and nausea. Full prescribing information for Imdelltra will be
posted here.
- On Thursday, the FDA announced the qualification of a
patient-reported outcome instrument through the Medical Device
Development Tools program, to assess frequency and bother of ocular
symptoms in certain patients after receiving bilateral intraocular
lens implants. The instrument can help quantify and provide
patients and clinicians with information regarding visual symptoms
and it assesses symptoms, perceptions of general vision, and
frequency of wearing glasses or contact lenses.
- On Thursday, the FDA provided an update on our ongoing
evaluation of quality and performance issues related to plastic
syringes made in China.
Specifically, the FDA announced an import alert for Zhejiang Longde
Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development
Group Co. Ltd. for not meeting device quality system requirements,
to prevent plastic syringes made by these China-based manufacturers from entering the
U.S. Additionally, the FDA recommendations have been updated to
include that users should also immediately transition away from
using plastic syringes made by these manufacturers, unless use of
these syringes is absolutely necessary until the transition to
syringes that are not manufactured in China is complete.
- On Wednesday, the FDA posted on its website its determination
that tara flour in human food does not meet the Generally
Recognized As Safe (or GRAS) standard and is an unapproved food
additive. The FDA's assessment of the ingredient is detailed in a
memo added to the agency's public inventory. Increased transparency
of our assessment of ingredients in the food supply is part of our
approach to enhance food chemical safety.
- On Wednesday, the FDA granted accelerated approval to
lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for
adults with relapsed or refractory follicular lymphoma (FL) who
have received two or more prior lines of systemic therapy. The most
common nonlaboratory adverse reactions (≥20%) were cytokine release
syndrome (CRS), headache, musculoskeletal pain, fatigue,
constipation, and fever. The FDA approved lisocabtagene maraleucel
with a Risk Evaluation and Mitigation Strategy due to the risk of
fatal or life-threatening CRS and neurologic toxicities. Full
prescribing information for Breyanzi will be posted here.
- On Wednesday, the FDA published the FDA Voices: "Protecting and
Advancing the Health of Women Through Policy, Research, Education
and Outreach," by Robert M. Califf,
M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate
Commissioner for Women's Health and Director of the Office of
Women's Health. Thirty years ago, the FDA's Office of Women's
Health (OWH) was established to promote the inclusion of women in
clinical trials and to provide leadership on topics related to the
health of women. Since its inception in 1994, OWH has been at the
forefront of ensuring that the unique health needs of women are
prioritized through a multifaceted approach that encompasses
policy, research, education, and outreach.
- On Wednesday, the FDA announced a webinar: Enforcement
Policies for Certain In Vitro Diagnostic Devices - Draft
Guidances that will be held on Wednesday, June 5, 2024, from 1-2 p.m. ET. During the webinar, the FDA will
provide an overview of two draft guidances and provide responses to
previously submitted questions. If you have questions about the
draft guidances that you wish to submit for possible discussion
during the webinar, please email CDRHWebinars@fda.hhs.gov. All
questions must be received by May 24,
2024, to be considered for the discussion. Questions will
not be taken during the live webinar. Registration is not
required.
- On Tuesday, the FDA approved expansions to the indications for
use (IFU) of the Beckon, Dickinson (BD) and Co. Onclarity HPV Assay
and the Roche Molecular Systems, Inc. cobas HPV Test. These tests
were each previously approved (P160037, P100020, and P190028,
respectively) for cervical cancer screening through the detection
of Human Papillomavirus (HPV) in cervical specimens collected in a
health care setting by a clinician. The expanded IFUs allow for the
patient to self-collect a vaginal swab in a health care setting
when the patient and the health care provider determine that it is
not possible for the clinician to collect a cervical specimen. The
approvals for use of self-collected vaginal specimens with these
HPV tests are the latest example of the FDA's continued commitment
to expanding cervical cancer screening options for patients,
particularly for individuals currently not participating/engaging
in routine screening.
Additional Resources:
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration