New Cancer Treatments Approved by FDA: A Guide for Families

AI-generated illustration, not actual Ameri-Care staff or patients. An older woman sits beside a care professional near a window at home.

New cancer treatments approved by the FDA offer significant hope, such as the recent approval of tucatinib for certain types of HER2-positive breast cancer. Understanding these advancements and how professional in-home skilled nursing can support a loved one through treatment is crucial for managing care and side effects effectively at home.

Key Takeaways

The FDA continues to approve new cancer treatments, including maintenance therapies that can extend the time before a cancer progresses.
A recent example is the approval of tucatinib in combination with other drugs for certain patients with advanced HER2-positive breast cancer.
Understanding clinical trial data, like progression-free survival, helps families grasp the potential benefits of a new therapy.
Managing side effects is a critical part of any cancer treatment plan, and skilled home health care plays a vital role in monitoring and patient education.
Medicare-certified home health agencies can provide skilled nursing and therapy services to support patients undergoing complex cancer treatments at home.

Understanding New FDA-Approved Cancer Treatments

For families navigating a cancer diagnosis, news of new treatment approvals from the U.S. Food and Drug Administration (FDA) can be a powerful source of hope. The FDA evaluates evidence on a drug's safety and effectiveness for its proposed use during the approval process. These treatments are studied in research and clinical trials; potential benefits, risks and effects on quality of life vary by treatment and patient.

One of the most promising areas of oncology is the development of targeted therapies. Unlike traditional chemotherapy that can affect all rapidly dividing cells, targeted drugs are designed to attack specific molecules involved in cancer cell growth and survival. This precision can lead to better outcomes and potentially fewer or different side effects. An important category within these advancements is maintenance therapy. After a patient completes an initial, more intensive round of treatment (known as induction therapy), a maintenance regimen may be prescribed to help keep the cancer in check for as long as possible. This approach is fundamental to managing many advanced cancers as chronic conditions.

A Closer Look: Tucatinib for HER2-Positive Breast Cancer

On October 7, 2026, the FDA approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy.

In the HER2CLIMB-05 trial, patients receiving tucatinib with trastuzumab and pertuzumab achieved a median progression-free survival of 24.9 months compared to 16.3 months in the placebo arm, with overall survival data not mature at analysis.

A significant recent development illustrates this progress. As the FDA announced, a new combination therapy was approved for a specific group of patients. This approval is for a maintenance treatment, designed to be used after initial therapy has been effective, to help delay the cancer's return or progression.

This is particularly meaningful for patients with HER2-positive breast cancer, a type that tends to be more aggressive. The term "unresectable" means the cancer cannot be completely removed with surgery, and "metastatic" means it has spread to other parts of the body. For individuals in this situation, treatments that can safely extend the period of disease control are invaluable. The approval was based on strong clinical trial evidence, which provides oncologists and their patients with the data needed to make informed decisions about their care plan. This is a clear example of how scientific innovation translates directly into new strategies for patient care.

What is Progression-Free Survival (PFS)?

When discussing clinical trials, you'll often hear the term "progression-free survival" or PFS. It's a critical endpoint that researchers use to measure how effective a new treatment is. In simple terms, PFS is the length of time during and after treatment that a patient lives with the cancer without it getting worse. The recent trial for tucatinib showed a meaningful improvement in PFS for patients who received the drug compared to those who received a placebo alongside the standard maintenance drugs. According to the FDA's report on the HER2CLIMB-05 trial, this data was a key factor in the drug's approval. Progression-free survival is not a measure of cure, overall survival or quality of life. Individual experiences vary, and the oncology team can explain what the trial results mean for a particular patient.

Managing Treatment at Home: The Role of Skilled Care

The prescribing information for tucatinib includes a boxed warning for hepatotoxicity, along with warnings for diarrhea, embryo-fetal toxicity, and increased serum creatinine without altering renal function.

While new treatments bring hope, they also come with a need for careful management. Every effective medication has potential side effects, and the FDA requires that this information be clearly communicated. For tucatinib, the prescribing information notes specific warnings that require monitoring.

This is where professional home health care becomes an essential part of the cancer care team. Managing a complex medication schedule and monitoring for side effects like liver toxicity (hepatotoxicity) or severe diarrhea can be overwhelming for patients and their families. A skilled nurse visiting the home can:

Educate the patient and family on what symptoms to watch for.
Perform assessments, such as checking vital signs and monitoring for subtle changes.
Communicate concerns to the oncologist's office for assessment and any changes the treating clinician considers appropriate.
Provide expert wound care if surgery was part of the treatment, or manage IV lines for other therapies.

These services, provided by a Medicare-certified agency, are designed to help patients remain safely and comfortably in their own homes while receiving high-level medical supervision. You can learn more about our comprehensive home health care services in Miami-Dade County to see how we support families like yours.

Comparing Support Services for Cancer Care at Home

Understanding the different types of in-home support can help you build the right care plan. Not all care is the same, and different needs require different professional skills.

If needed, swipe or scroll to read every column.

Service Type	How It Supports Cancer Patients	Medicare Coverage Note
Skilled Nursing (RN/LPN)	Manages medications, provides wound care, administers IV therapy, monitors for side effects, educates patient/family, communicates with doctors.	May be covered by Medicare Part A or B if criteria are met, including being homebound and requiring intermittent skilled care under a physician's order.
Physical/Occupational Therapy (PT/OT)	Helps regain strength, manage fatigue (a common side effect), improve safety with daily activities, and adapt the home environment.	May be covered if deemed medically necessary to restore function or establish a maintenance program. Read our in-home physical therapy guidance for more details.
Home Health Aide (HHA)	Assists with personal care like bathing, dressing, and grooming, which can be difficult during treatment. Works under the supervision of a nurse.	Typically covered by Medicare only when you are also receiving skilled nursing or therapy services.
Medical Social Worker (MSW)	Connects families with community resources, provides counseling and support, and helps with long-term care planning.	May be covered as part of the overall home health plan of care to help with social and emotional factors related to the illness.

AI-generated illustration, not actual Ameri-Care staff or patients. A care professional sits with an older man and another adult woman in a living room.

Finding Reliable Information and Support

The National Cancer Institute provides structured directories of FDA-approved drugs for specific cancers, childhood malignancies, and related conditions such as nausea and vomiting.

When a loved one is diagnosed with cancer, the amount of information can be overwhelming. It's essential to rely on trusted, authoritative sources. The National Cancer Institute (NCI), part of the U.S. National Institutes of Health, is an excellent resource. As the NCI website explains, they provide comprehensive, up-to-date information on various cancer types, treatments, and clinical trials.

While these resources are invaluable for education, they are meant to supplement, not replace, conversations with your loved one's oncology team. A home health agency acts as a bridge, helping to implement the doctor's complex treatment plan in the familiar comfort of home. This coordination supports care based on the patient's medical needs, comfort and clinician-directed plan. For physicians and discharge planners, we offer streamlined home health referrals for professionals to support communication during the transition to home care.

Questions to Ask Your Oncology Team

Click to view a checklist of questions for your next appointment

Use these questions as a starting point to facilitate a clear conversation with your oncologist or nurse practitioner about a new treatment. It's always a good idea to bring a notepad or a second person to help take notes.

What is the primary goal of this new treatment (e.g., cure, control, symptom management)?
What were the main results of the clinical trial for this drug (e.g., progression-free survival)?
What are the most common side effects we should watch for at home?
Are there any serious but less common side effects we need to be aware of?
Which symptoms should prompt an immediate call to the office versus waiting for the next appointment?
How will this treatment be administered (e.g., oral pill, infusion)?
How will we monitor the treatment's effectiveness and when?
Are there any interactions with my other medications or supplements?
What supportive care (like skilled nursing or physical therapy) might be beneficial during this treatment?

AI-generated illustration, not actual Ameri-Care staff or patients. A care professional stands beside an older man holding resistance-band handles at home.

Your Trusted Partner in Home Health Care

Navigating a cancer journey is challenging, but you don't have to do it alone. Ameri-Care Professional Service, Inc. is a licensed, nurse- and therapist-owned, Medicare-certified home health agency dedicated to providing compassionate and professional care throughout Miami-Dade County. From Miami Lakes and Hialeah to Homestead and Coral Gables, our team is committed to supporting patients and their families. We are CHAP-accredited, reflecting our commitment to the highest standards of care.

If your loved one is starting a new cancer treatment and needs support at home, we are here to help. Our skilled nurses and therapists work directly with your physician to create a personalized plan of care that addresses medical needs, manages side effects, and promotes the best possible quality of life. Contact us today to learn how we can provide excellent care in the comfort of your home. Call our office at (305) 826-8800 to request an assessment.

Frequently Asked Questions

What is 'maintenance therapy' for cancer?

Maintenance therapy is treatment given to patients after an initial, intensive therapy has successfully controlled the cancer. The goal is to prevent the cancer from returning or progressing for as long as possible. It's often a less intensive treatment, like an oral pill, designed to be taken long-term to manage the cancer as a chronic condition. This approach is common in advanced cancers like certain types of breast or lung cancer.

How can skilled nursing help with cancer treatment side effects at home?

A skilled nurse can assess symptoms, provide patient and caregiver education, and communicate concerns to the oncology team. Services such as IV-line or port care and wound care depend on clinical need, orders and agency capabilities. Monitoring does not guarantee that complications or hospital readmissions will be prevented; outcomes vary with the patient's condition and plan of care.

Does Medicare cover home health care during cancer treatment?

Medicare may cover intermittent skilled nursing care, physical therapy, and other home health services if the patient meets eligibility criteria. This typically requires that the patient is under a doctor's care, needs skilled services, and is considered homebound. Coverage is not guaranteed and depends on the individual's specific situation and plan of care. Our team can help you understand and navigate the eligibility requirements.

What's the difference between home health care and personal/companion care?

Home health care provides clinical, skilled services ordered by a physician, such as nursing, physical therapy, or speech therapy. Personal or companion care is non-medical and assists with daily living activities like bathing, meal preparation, and light housekeeping. While both are valuable, only skilled home health care can manage the complex medical needs associated with cancer treatment, like medication administration and side effect monitoring.

How do I find reliable information on new cancer drugs?

Always start with your oncology team. For your own research, use reputable sources like the U.S. Food and Drug Administration (FDA) website, which posts official approval announcements, and the National Cancer Institute (NCI) at cancer.gov. These sites provide accurate, evidence-based information for patients and families. Be cautious of forums or commercial sites that may offer anecdotal or unverified information.

Can physical therapy really help during cancer treatment?

Physical therapy may be part of an individualized cancer care plan. A therapist can assess mobility, strength, balance and activity tolerance, and coordinate an exercise plan with the oncology team when appropriate. Potential benefits and risks vary by patient and treatment; improvements in fatigue, independence or quality of life are not guaranteed. Occupational therapy can assess daily activities and recommend adaptations when indicated.

Authoritative sources

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