U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Drug Trials Snapshots: ROLVEDON
  1. Drug Approvals and Databases

Drug Trials Snapshots: ROLVEDON

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ROLVEDON Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

ROLVEDON (eflapegrastim)
(Roll veh don)
SPECTRUM PHARMACEUTICALS, INC.
Approval date: September 9, 2022


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ROLVEDON is a drug used to stimulate the growth of neutrophils, a type of white blood cell important in the body’s fight against infection in patients with cancers that do not involve bone marrow (non-myeloid cancers) who receive certain anti-cancer medicines that can suppress the bone marrow from producing blood cells and cause fever and low neutrophil count.

How is this drug used?

ROLVEDON is an injection given under the skin (subcutaneously) approximately 24 hours after administration of certain anticancer medicine (chemotherapy) that is toxic to cells.

Who participated in the clinical trials?

The FDA approved ROLVEDON based on evidence from two clinical trials of 643 patients with breast cancer treated with anti-cancer drugs that suppress the bone marrow from producing blood cells. The trials were conducted at 119 sites in 6 countries in the United States, Canada, South-Korea, Hungary, Poland, and India.

How were the trials designed?

ROLVEDON was evaluated in two clinical trials of 643 patients with breast cancer receiving anticancer treatment that is known to suppress the growth of blood-forming cells (red blood cells, white blood cells, and platelets) in the bone marrow. In both trials, patients were randomly assigned to either receive ROLVEDON or pegfilgrastim under the skin (subcutaneously) approximately 24 hours after anticancer treatment. Patients in both groups were evaluated and compared for the duration of severe neutropenia (a condition with lower-than-normal levels of neutrophils in the blood) during the first cycle of anticancer therapy.


DEMOGRAPHICS SNAPSHOT

Figure 1. Baseline Demographics by Sex (Efficacy Population)

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 2 (0.3%) male patients and 641 (99.7%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2. Baseline Demographics by Race (Efficacy Population)

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 496 (77%) White patients, 76 (12%) Black or African American patients, 54 (8%) Asian patients, and 17 (3%) Other patients participated in the clinical trial.

Source: Adapted from FDA Review
* Other includes 3 (<1%) American Indian or Alaska Native, 1 (<1%) Native Hawaiian or other Pacific Islander, and 13 (2%) patients with no race data reported.

Table 1. Demographics by Race

Race Number of Patients Percentage
White 496 77
Black or African American 76 12
Asian 54 8
Other 17 3
Not reported 13 2
American Indian or Alaska Native 3 <1
Native Hawaiian or Other Pacific Islander 1 <1

Source: Adapted from FDA Review

Figure 3. Baseline Demographics by Age (Efficacy Population)

Pie chart summarizing how many patients by age were in the clinical trial. In total, 400 (62%) patients younger than 65 years of age, 196 (31%) patients between 65 and 74 years of age, and 47 (7%) patients 75 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4. Baseline Demographics by Ethnicity (Efficacy Population)

Pie chart summarizing how many Hispanic and Not Hispanic patients were in the clinical trial. In total, 107 (17%) Hispanic or Latino patients and 536 (83%) Not Hispanic or Latino patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In patients receiving certain (myelosuppressive) anticancer treatment, ROLVEDON relative to pegfilgrastim was similar in decreasing the duration of severe neutropenia (a condition with abnormally low count of neutrophils) in Cycle 1 in two similarly designed clinical trials. Pegfilgrastim, like ROLVEDON is a drug approved to stimulate the growth of neutrophils.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: The number of males was small; therefore, differences in how ROLVEDON worked between males and females could not be determined.
  • Race: The effect of ROLVEDON was similar in White, Black/African-American, Asian and Other races of patients.
  • Age: The effect of ROLVEDON relative to pegfilgrastim was similar in patients younger than 65 years of age and 65 years of age and above.

What are the possible side effects?

ROLVEDON may cause serious side effects including:

  • Splenic rupture
  • A serious lung problem called acute respiratory distress syndrome
  • Serious allergic reactions
  • Sickle cell crisis in patients with sickle cell disorders
  • Kidney injury (glomerulonephritis)
  • Increased white blood cell count (leukocytosis)
  • Decreased platelet count (thrombocytopenia)
  • Fluid leak from blood vessels into the body’s tissues (capillary leak syndrome)
  • Potential for tumor growth stimulatory effects on malignant cells
  • Myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer
  • Inflammation of the aorta (aortitis)

The most common side effects are fatigue, nausea, diarrhea, bone pain, headache, fever, anemia, rash, myalgia, arthralgia, and back pain.

Were there any differences in side effects among sex, race and age?

  • Sex: The number of males was small; therefore, differences in side effects of ROLVEDON between males and females could not be determined.
  • Race: The occurrence of side effects was similar in White,, Black/African-American, Asian and Other races of patients.
  • Age: The occurrence of side effects was similar in patients younger than 65 years of age and 65 years of age and above.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

Back to Drug Trials Snapshots

Back to Top