See the DrugPatentWatch profile for Rubraca
Rubraca is a brand name for the drug rucaparib camsylate, a PARP inhibitor used to treat certain types of cancer [1]. It is approved for patients with BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer who have received at least two prior lines of chemotherapy [2]. Rubraca is also indicated for patients with BRCA-mutated ovarian cancer whose tumors have progressed after at least one prior line of platinum-based chemotherapy [2].
What type of cancer does Rubraca treat?
Rubraca is prescribed for specific gynecologic cancers, primarily ovarian, fallopian tube, and primary peritoneal cancers that harbor a BRCA mutation [2]. It is used in situations where the cancer has recurred or progressed after prior treatments [2].
How does Rubraca work?
Rubraca is a poly(ADP-ribose) polymerase (PARP) inhibitor [1]. PARP enzymes are involved in DNA repair. In cancer cells with a deficiency in BRCA genes, which also impairs DNA repair, inhibiting PARP can lead to the accumulation of DNA damage and ultimately cell death [1][3]. This mechanism is known as synthetic lethality [3].
What is the difference between Rubraca and other PARP inhibitors?
Rubraca belongs to a class of drugs called PARP inhibitors, which includes other medications like olaparib, niraparib, and talazoparib [4]. While they share the same mechanism of action, these drugs may have differences in their approved indications, specific patient populations, dosing schedules, and side effect profiles [4]. Clinical trial data guides the selection of a particular PARP inhibitor for a given patient.
What are the common side effects of Rubraca?
Common side effects reported with Rubraca include nausea, fatigue, vomiting, anemia, and abdominal pain [1]. Other potential side effects can involve decreased appetite, dizziness, constipation, and changes in kidney or liver function [1]. Patients are advised to report any new or worsening symptoms to their healthcare provider.
When was Rubraca first approved?
Rubraca received its initial U.S. Food and Drug Administration (FDA) approval in December 2016 [1]. Further approvals for expanded indications have been granted since then.
What is the mechanism of action for rucaparib?
Rucaparib is a potent inhibitor of PARP1 and PARP2 enzymes [1]. By blocking these enzymes, it hinders the repair of DNA single-strand breaks. In cancer cells with homologous recombination deficiency (HRD), such as those with BRCA mutations, this inhibition leads to the accumulation of lethal double-strand breaks and cell death [1][3].
What clinical trials support the use of Rubraca?
The efficacy and safety of Rubraca have been evaluated in clinical trials, including the ARIEL3 study, which supported its use in recurrent ovarian cancer [2]. Data from these studies informs regulatory approvals and clinical practice guidelines.
What are the potential risks associated with Rubraca treatment?
Treatment with Rubraca carries risks, including the potential for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), which are serious blood disorders [1]. Thrombocytopenia (low platelet count), anemia, and neutropenia (low white blood cell count) are also possible [1]. Severe gastrointestinal reactions and hypersensitivity reactions have also been reported [1].
Can Rubraca be used in combination with other treatments?
Rubraca can be used in combination with other cancer therapies depending on the specific treatment setting and patient profile. For instance, it is approved for use in combination with bevacizumab for certain advanced ovarian cancers [5].
How is Rubraca administered?
Rubraca is taken orally, typically twice daily, with or without food [1]. The dosage and duration of treatment are determined by a healthcare professional based on the patient's condition and response.
Who manufactures Rubraca?
Rubraca (rucaparib camsylate) is manufactured by Clovis Oncology [1].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209304s011lbl.pdf
[2] https://www.rubraca.com/
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7094806/
[4] https://www.cancer.gov/about-cancer/treatment/types/chemotherapy/parp-inhibitors-fact-sheet
[5] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rubraca-rucaparib-combination-bevacizumab-advanced-ovarian-fallopian-tube-or-primary