News in brief: Idelalisib FL approval maintained; New ASH president is lymphoma expert; Australian guidance on PCNSL


Idelalisib FL approval maintained

The P13 kinase inhibitor idelalisib (Zydelig) will remain on the market  for the treatment of follicular lymphoma (FL) in Australia and other countries despite being withdrawn in the US for this indication, according to manufacturer Gilead.

On 14 Jan the company released a statement saying the continued FDA approval for idelasib in the US to treat relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukaemia (SLL) was contingent upon providing evidence to confirm phase 2 trial results used to gain accelerated approval.

But the company noted that:  “as the treatment landscape for FL and SLL has evolved, enrolment into the confirmatory study has been an ongoing challenge. As a result, Gilead Sciences, … formally notified the FDA of its decision to voluntarily withdraw these indications from the US market.”

The company said approvals for idelalisib to treat FL in the EU, UK, Canada, Australia, New Zealand, and Switzerland are not affected by the proposed withdrawal. Similarly, approvals to treat relapsed chronic lymphocytic leukaemia (CLL) in the US and elsewhere are not affected.


New ASH president is lymphoma expert

The American Society of Hematology (ASH)’s new president for 2022 is Professor Jane Winter, a haematologist with a special interest in the management of lymphoma.

Professor Winter is a member of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University’s Feinberg School of Medicine, and is Professor of Medicine in the Division of Hematology and Oncology.

Her research interests include clinical and biologic markers of prognosis in diffuse large B-cell lymphoma, and clinical trials and translational research with novel agents in Hodgkin and non-Hodgkin lymphoma.

“As ASH President, I look forward to facilitating collaboration among ASH members and others who share our mission globally,” she said.

“It is through this vital scientific exchange that we can learn, adapt, and above all, improve care for those living with blood disorders. I am eager to welcome all who have an interest in haematology to the ASH family. I look forward to advancing our mission to promote research, high-quality equitable clinical care, education, training, and advocacy in haematology.”


Australian guidance on PCNSL

The Australasian Lymphoma Alliance has released a Consensus Practice Statement on the diagnosis and management of primary central nervous system lymphoma (PCNSL).

Developed by  a  panel  of  lymphoma  experts  with  particular  interest in PCNSL, the statement notes that the condition accounts for 1%  of  all  non-Hodgkin  lymphoma  (NHL).  However, advanced  patient  age,  adverse  disease  biology  and complexities of diagnosis and treatment render outcomes markedly inferior to systemic NHL.

Despite this, the statement notes that combination chemoimmunotherapy  protocols  containing  high dose methotrexate,  cytarabine  and  rituximab  have  improved  the  initial  response  rates  and  overall  outcomes  for  patients  with  PCNSL.

The authors, led by Dr Gareth Gregory of Monash Haematology also note that consolidation  strategies in eligible patients with radiotherapy or ASCT remain standard of care, balancing benefit of disease  control  against  short-  and  long-term  toxicities  of  therapy.

“Due  to  rarity  of  disease,  patients  should be enrolled into clinical trials whenever possible,” they advise.

Already a member?

Login to keep reading.

OR
Email me a login link
logo

© 2022 the limbic