is a multicenter, open-label, phase 1/2 study of selpercatinib
administered orally to patients with RET fusion-positive solid
tumors, RET-mutant MTC, and other tumors with RET
Occurrence of Dry Mouth
mouth was the most common AE reported in the overall population in
the LIBRETTO-001 trial (N = 746) with 300 patients (40%) reporting
Severity of the events was grade 1 (89%) and grade 2 (11%).5
mouth occurred more often in the NSCLC cohort (43%) compared to the
MTC cohort (39%).5
dry mouth was reported in 265 patients (36%). Drug-related dry mouth
occurred more frequently in the NSCLC cohort (40%) compared to the
MTC cohort (33%).5
dose modifications in the overall population (N = 746) included 2
patients having a drug interruption and 6 patients having a dose
reduction due to dry mouth.5
patients discontinued selpercatinib due to dry mouth.5
Local Oral Treatment
of data cut-off December 2019, 110 (16%) patients used a concomitant
local oral treatment (Table 1).
There were 53 (8%) patients that reported ‘other’
unspecified products used.5
1. Concomitant Local Oral Treatments Reported in LIBRETTO-001ab5
lactate with glucose oxidase
hydroxide with diphenhydramine
oxidase with lactoferrin
Names of products are written as reported.
Data cut-off December 2019.
Guidelines for Dry Mouth
is unable to provide treatment guidelines or recommendations. Table
2 provides a sampling of
resources that may provide helpful information for management of dry
mouth. Common themes found on these websites include the importance
teeth brushing and flossing, and
information regarding management of dry mouth including nutrition,
diet, and artificial saliva is also available on these sites.6-10
2. Internet Resources for Management of Dry Mouth6-10
Lilly does not promote or recommend 1 website over
Phase 1/2 study of LOXO-292 in patients with advanced solid tumors,
RET fusion-positive solid tumors, and medullary thyroid cancer
identifier: NCT03157128. Updated July 2, 2020. Accessed January 25,
Retsevmo [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Wirth LJ, Sherman E, Robinson B, et al. Efficacy of selpercatinib in
RET-altered thyroid cancers. N Engl J Med.
Drilon A, Oxnard GR, Tan DSW, et al. Efficacy of selpercatinib in
RET fusion-positive non-small-cell lung cancer. N Engl J
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Dry mouth (xerostomia). OncoLink. Published February 7, 2020.
Accessed March 10, 2020.
Weaver CH. Dry mouth or xerostomia. Cancer.Net.
Published May 2018. Accessed March 10, 2020.
Dry mouth-xerostomia. CancerConnect. Published March 18, 2019.
Accessed March 10, 2020.
Dry mouth. Chemocare. Accessed March 10, 2020.
The importance of dental health. CancerCare. Published March
17, 2016. Accessed March 10, 2020.
= Eli Lilly and Company
= medullary thyroid cancer
= non-small cell lung cancer
= rearranged during transfection
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.