Nivolumab (Opdivo) will be listed on the PBS from 1 August for head and neck squamous cell carcinoma
The listing, announced in advance by Federal minister for Health Greg Hunt, means almost 1,000 patients will get subsidised access to the immunotherapy drug they would otherwise have to pay about $50,000 per year for.
On 11 July Manufacturer Bristol-Myers Squibb (BMS) also welcomed the TGA registration of nivolumab in combination with another BMS immuno-oncology (I-O) agent, ipilimumab (Yervoy), for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.
The TGA approval was based on results of the clinical trial CheckMate 214 that showed nivolumab in combination with ipilimumab reduced the risk of death by 37% compared with sunitinib , in intermediate and poor-risk patients.
According to BMS, the combination therapy has been under consideration for patients with advanced renal cancer at the Pharmaceutical Benefits Advisory Committee meeting in July.
The new indication for nivolumab was approved under the TGA’s new priority review system.
Another drug assessed via priority review is apalutamide (Erlyand ) which has been TGA approved for treatment of patients with non-metastatic, castration-resistant prostate cancer (nmCRPC).
Apalutamide is a next-generation oral androgen receptor (AR) antagonist and the first hormonal treatment approved for patients with nmCRP .
According toDr Paul Mainwaring, medical oncologist, Canossa Private Hospital, Brisbane, nmCRPC refers to patients with serum PSA levels that have begun to rise despite a low serum testosterone level (<50 ng/dL) and who lack detectable metastases on a bone scan, CT or MRI.
” Prostate cancer becomes resistant to androgen deprivation therapy (ADT) in nearly all patients at some stage, and at this point PSA levels begin to rise, and the rise of radiographically-detectable metastatic disease increases,” he said.
“Having efficacious and tolerable treatments to prevent or delay the development of metastatic disease in the nmCRPC setting has been a significantly unmet medical need, until now. Apalutamide is set to be the first AR-antagonist treatment for patients early in their disease journey but who have high risk of death within three years. This will replace the anxiety-inducing standard of care option of ‘active surveillance’ for disease progression while on ADT,” he added.
Meanwhile, ibrutinib (Imbruvica) has been announced as another new listing on the PBS from August 1 for relapsed or refractory mantle cell lymphoma (MCL).
The listing expands reimbursed access to the Bruton’s tyrosine kinase inhibitor beyond refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
It will also spare patients the high cost of $134,000 per year for a typically aggressive disease.
When the Pharmaceutical Benefits Advisory Committee (PBAC) approved the PBS listing application for ibrutinib in MCL in March 2018 it noted this was an area of high clinical need for the 1000 patients living with the disease in Australia.
“In relapsed/refractory MCL ibrutinib provides, for some patients, a significant improvement in efficacy over R-CHOP and a reduction in toxicity versus active treatment with R-CHOP,” it concluded.
Associate Professor Constantine Tam, Disease Group Lead in Low Grade Lymphoma & CLL at the Peter MacCallum Cancer Centre and Director of Haematology at St Vincent’s Hospital Melbourne, welcomed improved access to the drug.
In a statement released by manufacturer from Janssen, Professor Tam said mantle cell lymphoma was typically diagnosed at an advanced stage and that even if remission was achieved with chemotherapy, the vast majority of patients would relapse. Average survival from relapse was one to two years, he said.
“Until now, there has been no globally recognised standard of care for these patients. Imbruvica is the first agent to show a significant clinical benefit and become available on the PBS for patients with relapsed or refractory MCL,” he said.
From 1 August the PBS will also list pegfilgrastim (Neulasta) and peginterferon alfa-2A (Pegasys) to support patients during chemotherapy.